Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01377051
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2011-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D013610', 'term': 'Tachycardia'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510790', 'term': 'indacaterol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-28', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-06-17', 'lastUpdatePostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra Thoracic Gas Volume (ITGV)', 'timeFrame': '60 minutes after drug inhalation', 'description': 'A complete body plethysmografic test will be performed after indacaterol inhalation'}], 'secondaryOutcomes': [{'measure': 'Forced Expired Volume in the first second (FEV1)', 'timeFrame': '60 minutes after drug inhalation', 'description': 'Will be performed: spirometry, Arterial blood sample, measurement of blood pressure and cardiac frequency. All these parameters will be tested 60 minutes after inhalation of Indacaterol 300 micrograms (mcg).'}, {'measure': 'Partial pressure of arterial oxygen (PaO2)', 'timeFrame': '60 minutes after drug inhalation', 'description': 'Arterial gas analysis will be performed evaluating all arterial gases'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'Inspiratory capacity', 'Residual volume', 'Total lung resistance', 'Arterial Oxygen'], 'conditions': ['COPD', 'Lung Diseases', 'Dyspnea', 'Hypoxemia', 'Tachycardia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.', 'detailedDescription': 'Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.\n\nEvaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signature of consensus\n* COPD diagnosis\n* Age from 50 to 85 years old\n* history of COPD at least of one year\n* respiratory stable conditions at least of one month\n* Any basal FEV1 expressed in % of predicted value\n* FEV1/ Forced Vital Capacity (FVC) less than 70%\n* Former or active smokers with at least a smoking history of 20 pack year\n\nExclusion Criteria:\n\n* Pregnancy\n* FEV1/FVC more than 70%\n* Known deficit of alpha 1 antitrypsin\n* Subjects submitted to a Lung Volume Reduction Surgery (LVRS)\n* Subjects with known positivity to Human Immunodeficiency Virus (HIV)\n* Misuse of alcool or drugs\n* Absence of compliance in performing respiratory tests'}, 'identificationModule': {'nctId': 'NCT01377051', 'briefTitle': 'Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.', 'orgStudyIdInfo': {'id': '654CEC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bronchodilator', 'description': 'Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.', 'interventionNames': ['Drug: Indacaterol maleate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Will be administered with the same device by a third independent investigator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Indacaterol maleate', 'type': 'DRUG', 'otherNames': ['Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta'], 'description': 'Dry powered, 300 mcg, only one inhalation with 24 hours duration', 'armGroupLabels': ['Bronchodilator']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dry powered, same to study drug, only one inhalation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20138', 'city': 'Milan', 'country': 'Italy', 'facility': 'Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Pierachille Santus, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Salvatore Maugeri', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Pierachille Santus', 'investigatorAffiliation': 'University of Milan'}}}}