Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-07 @ 2:57 AM
Study NCT ID:
NCT02039050
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2014-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Long-Acting Muscarinic Antagonists in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'C542859', 'term': 'aclidinium bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in trough R5 from baseline after chronic dosing', 'timeFrame': '4 to 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF)', 'timeFrame': '4 to 6 weeks'}, {'measure': 'Spirometry (FEV1, FEF25-75, FVC)', 'timeFrame': '4 to 6 weeks'}, {'measure': 'Relaxed VC (RVC) with RVC to FVC ratio', 'timeFrame': '4 to 6 weeks'}, {'measure': 'Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score)', 'timeFrame': '4 to 6 weeks'}, {'measure': 'Domiciliary PIKO-6 measurements for FEV1 and FEV6', 'timeFrame': '4 to 6 weeks'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ)", 'timeFrame': '4 to 6 weeks'}, {'measure': 'Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)', 'timeFrame': '4 to 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Disease, Chronic Obstructive', 'Long-acting muscarinic antagonists', 'Impulse oscillometry'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '26758884', 'type': 'RESULT', 'citation': 'Manoharan A, Morrison AE, Lipworth BJ. Effects of Adding Tiotropium or Aclidinium as Triple Therapy Using Impulse Oscillometry in COPD. Lung. 2016 Apr;194(2):259-66. doi: 10.1007/s00408-015-9839-y. Epub 2016 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a new LAMA called aclidinium has been approved for use in COPD. There are potentially important differences between these two medications that might have an impact on the treatment of COPD patients.\n\nIn this study we aim to compare the effects of tiotropium and aclidinium in people with COPD. The main comparison will be done using a very sensitive breathing test called impulse oscillometry'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female volunteers aged 40-80 years with moderate to severe COPD (GOLD Stage 2, 3).\n* On inhaled corticosteroids / long-acting beta agonists\n* FEV1 30-80% predicted and FEV1/FVC \\<70%.\n* Smoking history ≥10 pack-years.\n* Ability to give informed consent\n* Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being\n\nExclusion Criteria:\n\n* Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis\n* A COPD exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required)\n* Any clinically significant medical condition that may endanger the health or safety of the participant\n* Known or suspected sensitivity to/intolerance of investigational medicinal product\n* Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma\n* Pregnancy or lactation\n* Unable to comply with the procedures of the protocol"}, 'identificationModule': {'nctId': 'NCT02039050', 'acronym': 'MAN04', 'briefTitle': 'Evaluation of Long-Acting Muscarinic Antagonists in COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Dundee'}, 'officialTitle': 'Proof of Concept Evaluation of Drug-Device Interaction With Aclidinium Bromide Via Genuair® and Tiotropium Bromide Via HandiHaler® in COPD Using Impulse Oscillometry', 'orgStudyIdInfo': {'id': '2013RC09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tiotropium', 'description': 'Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.', 'interventionNames': ['Drug: Tiotropium']}, {'type': 'EXPERIMENTAL', 'label': 'Aclidinium', 'description': 'Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.', 'interventionNames': ['Drug: Aclidinium']}], 'interventions': [{'name': 'Tiotropium', 'type': 'DRUG', 'armGroupLabels': ['Tiotropium']}, {'name': 'Aclidinium', 'type': 'DRUG', 'armGroupLabels': ['Aclidinium']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Asthma and Allergy Research Group, University of Dundee', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Brina Lipworth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dundee'}, {'name': 'Arvind Deva Manoharan, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dundee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dundee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Almirall Limited', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Allergy and Pulmonology', 'investigatorFullName': 'Brian J Lipworth', 'investigatorAffiliation': 'University of Dundee'}}}}