Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-07 @ 11:49 PM
Study NCT ID:
NCT03104634
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542859', 'term': 'aclidinium bromide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Matched placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inspiratory pleural pressures at rest and throughout incremental exercise (cmH2O)', 'timeFrame': 'After 7-days of active or placebo drug', 'description': 'Mean difference in inspiratory pleural pressure measured by esophageal manometry at rest and throughout incremental exercise'}], 'secondaryOutcomes': [{'measure': 'Resting and exercise-induced changes in plasma natriuretic peptide concentrations (plasma concentration)', 'timeFrame': 'After 7-days of active or placebo drug', 'description': 'Mean difference in atrial natriuretic peptide (exercise induced-changes) and n-terminal pro-B-type natriuretic peptide (resting).'}, {'measure': 'Resting and dynamic lung volumes (end-inspiratory/end-expiratory lung volume)', 'timeFrame': 'After 7-days of active or placebo drug', 'description': 'Static and operating lung volumes'}, {'measure': 'Effect modification by gender (self-reported).', 'timeFrame': 'After 7-days of active or placebo drug', 'description': 'Interaction term added to regression model for gender.'}, {'measure': 'Effect modification by smoking status (self-reported).', 'timeFrame': 'After 7-days of active or placebo drug', 'description': 'Interaction term added to regression model for smoking status.'}, {'measure': 'Effect modification by hypertension status (Joint National Committee criteria).', 'timeFrame': 'After 7-days of active or placebo drug', 'description': 'Interaction term added to regression model for hypertension status.'}, {'measure': 'Effect modification by hyperinflation severity (Residual lung volume).', 'timeFrame': 'After 7-days of active or placebo drug', 'description': 'Interaction term added to regression model for hyperinflation severity.'}, {'measure': 'Effect modification by spirometric chronic obstructive pulmonary disease (COPD) status (forced expired volume in 1 second-to-forced vital capacity ratio below 0.7).', 'timeFrame': 'After 7-days of active or placebo drug', 'description': 'Interaction term added to regression model for spirometric COPD status.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'This short-term study aims to prove the potential cardio-protective physiological effect of inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures.\n\nSmoking is associated with gas-trapping (hyperinflation), even in the absence of chronic obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large negative inspiratory pleural pressures, which are transmitted to the surface of the heart and increase cardiac wall stress.\n\nInhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Self-reported gender', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current and former smokers with ≥20 pack-years of smoking history\n* Gas-trapping (residual volume \\>110% predicted)\n\nExclusion Criteria:\n\nPhysician-diagnosis of chronic obstructive pulmonary disease in the past 1 year and regular use of long-acting antimuscarinic (LAMA) and/or long-acting beta-agonist (LABA) (i.e., at least 30 consecutive days)\n\n* Physician-diagnosis of asthma in the past 5 years\n* Regular inhaled corticosteroid (ICS) use in the past 5 years (i.e., at least 30 consecutive days)\n* Physician-diagnosis of other lung diseases (sarcoidosis, tuberculosis, cystic fibrosis, pulmonary fibrosis, lung cancer), or long-term oxygen therapy\n* Respiratory tract infection within 4-weeks\n* Physician-diagnosis of arrhythmia, or significant valvular disease.\n* Physician-diagnosis of myocardial infarction, unstable angina or heart failure requiring unscheduled outpatient or emergency department visit within 6-months.\n* Arrhythmia or prolonged corrected QT (QTc) on electrocardiogram.\n* Inability to use study inhaler\n* Glaucoma\n* Benign prostatic hypertrophy\n* Pregnancy\n* Allergy to the study treatment, salbutamol, lidocaine, or severe milk protein allergy (note: lactose intolerance is not an exclusion criteria)\n* Contraindications to anti-cholinergic, beta-agonist, or cardiopulmonary exercise testing with manometry\n* Inability to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT03104634', 'briefTitle': 'The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers: a Randomized, Double-blind, Placebo-controlled, Cross-over Trial', 'orgStudyIdInfo': {'id': '2017-2748'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active arm', 'description': 'Aclidinium bromide/formoterol fumarate dihydrate 400 mcg/12 mcg Twice daily (once in the morning, once in the evening) 7-days', 'interventionNames': ['Drug: Aclidinium bromide/formoterol fumarate dihydrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Placebo Twice daily (once in the morning, once in the evening) 7-days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aclidinium bromide/formoterol fumarate dihydrate', 'type': 'DRUG', 'otherNames': ['DUAKLIR™ GENUAIR®'], 'description': 'Cross-over design with washout interval. Randomized order of active and placebo arm', 'armGroupLabels': ['Active arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo and delivery device matched to active intervention', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre Research Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'B M Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Benjamin McDonald Smith', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}