Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 12:34 AM
Study NCT ID:
NCT03651895
Status:
COMPLETED
Last Update Posted:
2025-02-18
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metformin to Reduce Airway Glucose in COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'h.farne@imperial.ac.uk', 'phone': '+44 (0)20 7589 5111', 'title': 'Farne Hugo', 'organization': 'Imperial College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Adverse events were reviewed at every study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'Metformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 7, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Placebo\n\nPlacebo: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 7, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural related adverse event', 'notes': 'Breathlessness or lightheadedness during sputum induction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Exacerbation of COPD with hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sputum Glucose Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Metformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '68.92', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '131.1'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'The median concentration of glucose in sputum following 3 months treatment with metformin or placebo.', 'unitOfMeasure': 'µM', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nasal Glucose Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Metformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '12.56', 'groupId': 'OG000', 'lowerLimit': '5.92', 'upperLimit': '28.28'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '6.19', 'upperLimit': '27.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'The median concentration of glucose in nasal samples following 3 months treatment with metformin or placebo.', 'unitOfMeasure': 'µM', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sputum Bacterial Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Metformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '3 months', 'description': 'The bacterial load in sputum using qPCR was not measured. Therefore, data were not collected', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected. Participants with infection were excluded from the study.'}, {'type': 'SECONDARY', 'title': 'Sputum Inflammatory Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Metformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '3 months', 'description': 'The median concentration of inflammatory cells and cytokines in sputum was not measured. Therefore, data were not collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected. Participants with infection were excluded from the study.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Score (COPD Assessment Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Metformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '26.8'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '23.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month', 'description': "The COPD Assessment Test (CAT): the CAT features 8 questions ranked from 0-5 with a minimum score of 0 and maximum possible score of 40. Higher scores indicate a greater impact on patient health due to their COPD, a difference of ≥2 is considered meaningful.\n\nThe questionnaire's were completed by every participant at every visit up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Quality of Life Score (St George's Respiratory Questionnaire)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Metformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '61'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '54.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month', 'description': "St George's Respiratory Questionnaire (SGRQ): the SGRQ contains 50 items with a minimum score of 0 and a maximum score of 100. Higher scores indicate a greater impact on quality of life due to COPD and a difference of ≥4 is meaningful\n\nThe questionnaire's were completed by every participant at every visit up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lung Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Metformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '87.4'}, {'value': '66.1', 'groupId': 'OG001', 'lowerLimit': '46.7', 'upperLimit': '85.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month', 'description': 'FEV1(Forced Expiratory Volume Test) was performed up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.', 'unitOfMeasure': 'Litres (L)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin First (Before Crossover), Placebo Second (After Crossover)', 'description': 'Metformin 500 milligrams (mg)/1 gram (g) twice daily.\n\nMetformin: 500mg twice daily was administered for one week and increased to 1g twice daily for the reminder of the 3 months.\n\nPlacebo\n\nPlacebo: The drug was administered with the same regime as the metformin.'}, {'id': 'FG001', 'title': 'Placebo First (Before Crossover), Metformin Second (After Crossover)', 'description': 'Metformin 500 milligrams (mg)/1 gram (g) twice daily.\n\nMetformin: 500mg twice daily was administered for one week and increased to 1g twice daily for the reminder of the 3 months.\n\nPlacebo\n\nPlacebo: The drug was administered with the same regime as the metformin.'}], 'periods': [{'title': 'First Drug Assignment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': '1 Month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': '3 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Second Drug Assignment - Crossover', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': '1 Month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Overall treatment time 6 months (2 milestones at 1 and 3 months)', 'preAssignmentDetails': '14 participants were enrolled but 11 withdrew for lower/upper respiratory tract infections (LRTI/URTI) Cough and Vomiting. At 3 months there was a washout and a crossover thereafter.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group & Placebo Group', 'description': 'Placebo\n\nOr\n\nMetformin 500mg/1g bd\n\nMetformin: The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '67.9', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '74'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Forced Expiratory Volume in One Second (FEV1) Percentage (%) Predicted', 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'spread': '17.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage(%) predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forced Vital Capacity (FVC) Percentage (%) Predicted', 'classes': [{'categories': [{'measurements': [{'value': '100.3', 'spread': '15.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage (%) predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Peak Expiratory Flow (PEF) Percentage (%) Predicted', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '22.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage (%) predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'COPD Assessment Test (CAT)', 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "St George's Respiratory Questionnaire (SGRQ)", 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'spread': '16.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sputum Glucose Concentration', 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'BG000', 'lowerLimit': '0.02', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'µmol', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-03', 'size': 700189, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-04T10:38', 'hasProtocol': True}, {'date': '2022-08-03', 'size': 193642, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-04T10:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2018-08-02', 'resultsFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-17', 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum Glucose Concentration', 'timeFrame': '3 months', 'description': 'The median concentration of glucose in sputum following 3 months treatment with metformin or placebo.'}], 'secondaryOutcomes': [{'measure': 'Nasal Glucose Concentrations', 'timeFrame': '3 months', 'description': 'The median concentration of glucose in nasal samples following 3 months treatment with metformin or placebo.'}, {'measure': 'Sputum Bacterial Load', 'timeFrame': '3 months', 'description': 'The bacterial load in sputum using qPCR was not measured. Therefore, data were not collected'}, {'measure': 'Sputum Inflammatory Markers', 'timeFrame': '3 months', 'description': 'The median concentration of inflammatory cells and cytokines in sputum was not measured. Therefore, data were not collected.'}, {'measure': 'Quality of Life Score (COPD Assessment Test)', 'timeFrame': '1 month', 'description': "The COPD Assessment Test (CAT): the CAT features 8 questions ranked from 0-5 with a minimum score of 0 and maximum possible score of 40. Higher scores indicate a greater impact on patient health due to their COPD, a difference of ≥2 is considered meaningful.\n\nThe questionnaire's were completed by every participant at every visit up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that."}, {'measure': "Quality of Life Score (St George's Respiratory Questionnaire)", 'timeFrame': '1 month', 'description': "St George's Respiratory Questionnaire (SGRQ): the SGRQ contains 50 items with a minimum score of 0 and a maximum score of 100. Higher scores indicate a greater impact on quality of life due to COPD and a difference of ≥4 is meaningful\n\nThe questionnaire's were completed by every participant at every visit up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that."}, {'measure': 'Lung Function', 'timeFrame': '1 month', 'description': 'FEV1(Forced Expiratory Volume Test) was performed up to 8 times: V1 is at the baseline, then V2-4 are at monthly intervals. V5 is at the baseline after crossing arms -1 month washout, V6-8 are monthly after that.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death worldwide and affects 1.2 million people in the UK, costing the NHS \\>£800 million annually. COPD patients are more susceptible to bacterial infections and both chronic and acute infections are common. COPD patients with chronic lung bacterial infection have worse quality of life, faster disease progression, more symptoms and frequent exacerbations. Acute infections are the main cause of COPD exacerbations which cause COPD patients to become acutely unwell and often result in hospitalisation especially in the winter. Antibiotics are frequently used to treat COPD exacerbations and this contributes to the development of antibiotic resistance. Therefore there is a need to develop antibiotic-independent approaches to reducing or preventing bacterial infection in COPD.\n\nThe investigators have carried out work in in animal studies and in humans showing that there is a link between high levels of glucose in the lung and bacterial lung infection. Levels of glucose in the lung are higher in COPD patients compared with people without COPD. These higher glucose levels support greater bacterial growth probably because glucose is a nutrient for bacteria. Therefore reducing airway glucose has the potential to inhibit bacterial growth in COPD patients.\n\nIn animal studies the investigators have demonstrated that the diabetic drug metformin decreases airway glucose and bacterial growth. The investigators wish to determine if metformin can achieve the same effects in COPD patients. Metformin is safe and cheap, and has been extensively used in COPD patients with diabetes with an excellent safety record. The primary aim of this study will be to determine whether metformin reduces lung glucose in a small group of non-diabetic COPD patients. If it demonstrates that metformin reduces lung glucose concentrations it will justify a larger clinical trial of metformin as a treatment for COPD.', 'detailedDescription': "Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death worldwide and affects 1.2 million people in the UK, costing the NHS \\>£800 million annually. COPD patients are more susceptible to both chronic and acute bacterial infections. Patients with chronic lung bacterial infection have worse quality of life, faster disease progression, more symptoms and frequent exacerbations. Acute infections are the main cause of acute COPD exacerbations which cause COPD patients to become acutely unwell and often result in hospitalisation especially in the winter. Bacteria are detected in 50-60% of COPD exacerbations. Antibiotics are frequently used to treat COPD exacerbations and this contributes to the development of antibiotic resistance. Therefore any intervention that prevents or reduces bacterial infection in COPD, especially if it is not an antibiotic, will have major benefits for COPD patients, the NHS and for society as a whole.\n\nIt is likely that there are many reasons why COPD patients are more susceptible to bacterial infections. From experimental work the investigators have carried out one of the reasons may be high glucose concentrations in the lung.\n\nIn healthy lungs glucose levels are kept low and this may be a mechanism that inhibits bacterial growth by depriving them of an essential nutrient. In animal studies the investigators have demonstrated that when levels of glucose in the lung are high, bacterial lung infection is more common. The investigators measured lung glucose concentrations in COPD patients and found that they are higher compared with people without COPD. COPD patients with higher levels of glucose also had more bacteria in their lungs and sputum samples from COPD patients with higher glucose concentrations supported greater bacterial growth in the laboratory.\n\nTherefore this study was the first to link elevated glucose in the lung to bacterial infection in COPD. Therefore reducing airway glucose has the potential to inhibit bacterial growth in COPD patients.\n\nStudy Design The proposed study will be a randomised, double-blinded, placebo-controlled, cross-over study of metformin in COPD patients. The primary outcome will be sputum glucose after 3 months' treatment with metformin compared with sputum glucose in those taking placebo. In order to account for potential withdrawals 40 subjects will be recruited.\n\nStudy Procedures Potential participants will attend for a screening visit where they will have a full medical history, a physical examination and spirometry carried out to confirm the diagnosis of COPD. A blood test will also be done to measure kidney and liver function and blood glucose to exclude undiagnosed diabetes, kidney disease or liver disease.\n\nIf they fulfil the entry criteria and consent to taking part in the study they will have a baseline visit prior to being randomised.\n\nThe baseline visit will include:\n\n1. Physical examination and measurement of vital signs\n2. Completion of quality of life (St George's Respiratory Questionnaire (SGRQ)) and symptom questionnaires (COPD Assessment Test (CAT))\n3. Collection of samples. The samples collected will include blood samples, nose samples collected using nasal synthetic absorption matrix (SAM) strips and induced sputum.\n\nAfter baseline assessment, subjects will either be commenced on metformin (500mg twice a day after meals) or placebo for 3 months during which time the participants will have monthly visits. At these visits the same assessments and sampling as the baseline will be carried out, together with collection of data regarding exacerbations and adverse events. Following a 2 week washout period the subjects will crossover to the other study arm for another 3 months and follow the same study protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 40 and 75 years\n* Clinical diagnosis of COPD confirmed with spirometry (Post-bronchodilator FEV1/FVC \\<70%).\n* Smoking history \\>15 pack years\n* Absence of infection \\>8 weeks prior to study entry\n* No use of antibiotics and/or oral corticosteroids \\>8 weeks prior to study entry\n* Able to understand and consent to the study procedures\n\nExclusion criteria:\n\n* Diabetes including diabetes diagnosed at screening\n* History of hepatic or renal impairment or diagnosed on screening bloods\n* Patients already taking metformin irrespective of indication\n* Known allergy or hypersensitivity to metformin\n* Pregnancy or breastfeeding\n* Any other significant medical condition likely to interfere with the study\n* Unable to provide informed consent\n* Excessive alcohol intake (\\>21 units/week)\n* BMI \\< 18.5kg/m2'}, 'identificationModule': {'nctId': 'NCT03651895', 'briefTitle': 'Metformin to Reduce Airway Glucose in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Metformin to Reduce Airway Glucose in COPD Patients', 'orgStudyIdInfo': {'id': '18SM4819'}, 'secondaryIdInfos': [{'id': '2018-001755-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group', 'description': 'Metformin 500mg/1g bd', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'The Drug was administered 500 mg twice daily for one week and increased to 1g twice daily for the reminder of the 3 months.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': "Imperial College Respiratory Research Unit, St Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Sebastian Johnston', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}