Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-02 @ 7:42 AM
Study NCT ID:
NCT02541006
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2015-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe 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'}], '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-12', 'studyFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)', 'timeFrame': 'prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose'}, {'measure': 'Percantage (%) change from baseline in FEV1 and FVC', 'timeFrame': 'prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose'}, {'measure': 'Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours -Post-dose', 'timeFrame': 'Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose'}, {'measure': '- Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response', 'timeFrame': 'Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose'}], 'secondaryOutcomes': [{'measure': 'Time to onset of bronchodilator effect and maximum effect', 'timeFrame': '15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose'}, {'measure': 'Adverse Events', 'timeFrame': 'predose and up to 24 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FEV1', 'FVC', 'AUC 0-24', 'bronchodilator efficacy', 'tiotropium'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '27920513', 'type': 'BACKGROUND', 'citation': 'Yildiz P, Bayraktaroglu M, Gorgun D, Secik F. Bronchodilator efficacy of 18 mug once-daily tiotropium inhalation via Discair(R) versus HandiHaler(R) in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial. Int J Chron Obstruct Pulmon Dis. 2016 Nov 22;11:2859-2867. doi: 10.2147/COPD.S119114. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 40 years and older with moderate to severe COPD diagnosis\n* Current/former smokers with at least a 10 pack-year history of cigarette smoking\n* Patients with established clinical COPD and severity defined as a post-broncodilator FEV1/FVC ratio of ≤0.70 and FEV1 ≤80 % of predicted normal at screening\n* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods\n* Have no excacerbation within last 4 weeks\n* Hava capability of communicate with investigator\n* Accept to adapt the procedures of study protocol\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* History of hypersensitivity to anticholinergics\n* Diagnosis of asthma\n* History of alergic rinit and athopy\n* Current or history of lung cancer\n* Known symptomatic prostatic hypertrophy requiring drug therapy\n* Known narrow-angle glaucoma requiring drug therapy\n* Have experienced exacerbation of COPD or lower respiratory inflammatory disease requiring use of antibiotics, oral or parenteral corticosteroids (CS) within 4 weeks prior to screening visit and/or during run-in period\n* Patients vaccinated with poored virüs vaccinate within 2 weeks prior to screening visit and/or during run-in period\n* Patients with a recent history of myocardial infarction, acute ischemic cardiac disease or severe cardiac arrhythmia requiring drug therapy\n* Women who are pregnant or lactating or are planning on becoming pregnant during the study'}, 'identificationModule': {'nctId': 'NCT02541006', 'briefTitle': 'Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neutec Ar-Ge San ve Tic A.Ş'}, 'officialTitle': 'A Randomized, Parallel-group, Phase IV Study to Compare the Bronchodilator Efficacy of Tiotropium (18 µg Once Daily [od]) Delivered Via a DISCAIR With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD', 'orgStudyIdInfo': {'id': 'Neu-21.12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tiotropium 18 mcg dry powder for inhalation', 'description': 'Tiotropium 18 mcg dry powder for inhalation, one inhalation, once daily with the DISCAIR', 'interventionNames': ['Drug: Tiotropium 18 mcg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SPIRIVA 18 mcg HANDIHALER', 'description': 'Tiotropium 18 mcg dry powder capsul for inhalation one capsule once daily with the HandiHaler', 'interventionNames': ['Drug: Tiotropium 18 mcg']}], 'interventions': [{'name': 'Tiotropium 18 mcg', 'type': 'DRUG', 'description': 'tiotropium 18 mcg once a day', 'armGroupLabels': ['SPIRIVA 18 mcg HANDIHALER', 'Tiotropium 18 mcg dry powder for inhalation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Neutec Ar-Ge San ve Tic A.S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neutec Ar-Ge San ve Tic A.S Clinical Trial'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neutec Ar-Ge San ve Tic A.Ş', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}