Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 6:24 PM
Study NCT ID:
NCT00365560
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2006-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-10', 'studyFirstSubmitDate': '2006-08-16', 'studyFirstSubmitQcDate': '2006-08-16', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period'}], 'secondaryOutcomes': [{'measure': 'FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc.'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '21636120', 'type': 'DERIVED', 'citation': 'Kerstjens HA, Disse B, Schroder-Babo W, Bantje TA, Gahlemann M, Sigmund R, Engel M, van Noord JA. Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Aug;128(2):308-14. doi: 10.1016/j.jaci.2011.04.039. Epub 2011 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOutpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (GINA step 4), smoking history \\< 10 pack years and \\>= 1 year smoking cessation; Patients must be symptomatic\n\nExclusion Criteria:\n\nPatients\n\n* with a recent history (i.e., six months or less) of myocardial infarction,\n* who have been hospitalized for heart failure (NYHA class III or IV) within the past year,\n* with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year,\n* with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years,\n* who have undergone thoracotomy with pulmonary resection,\n* with moderate to severe renal impairment (creatinine clearance = 50 mL/min)'}, 'identificationModule': {'nctId': 'NCT00365560', 'briefTitle': 'An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 Mcg (2 Actuations of 2.5 Mcg) and 10 Mcg (2 Actuations of 5 Mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler® as Add-on Therapy in Patients With Severe Persistent Asthma', 'orgStudyIdInfo': {'id': '205.341'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tiotropium', 'type': 'DRUG'}, {'name': 'placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'K?benhavn NV', 'country': 'Denmark', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Odense C', 'country': 'Denmark', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'city': 'Gelnhausen', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.20164, 'lon': 9.18742}}, {'city': 'Gro?hansdorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Rudersdorf', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.1, 'lon': 11.45}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Wiesloch', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.29504, 'lon': 8.69846}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'lokatie Langendijk', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Polikliniek longziekten', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Polikliniek longziekten', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Polikliniek Longziekten', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Hengelo', 'country': 'Netherlands', 'facility': 'Polikliniek longziekten', 'geoPoint': {'lat': 52.26583, 'lon': 6.79306}}, {'city': 'Zutphen', 'country': 'Netherlands', 'facility': 'lokatie het Spittaal', 'geoPoint': {'lat': 52.13833, 'lon': 6.20139}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim Study Coordinator', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}}}}