12-Week Tiotropium 18?g q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma for Safety and Efficacy
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00152984
First received: September 8, 2005
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive Asthma |
Drug: Tiotropium inhalation capsules Drug: Placebo inhalation capsules |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A 12-week Randomized, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Safety and Efficacy of Tiotropium 18 ?g qd in Patients With COPD and a Pre-existing Diagnosis of Asthma |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline at visit 2 (day 1) for the time period from pre-dose to 6 hours post dose (AUC(0-6hours)FEV1) after 12 weeks of randomised treatment on visit 4 (day 85).
Secondary Outcome Measures:
- Secondary endpoints include additional FEV1 and FVC endpoints, morning and evening expiratory flow rate (PEFR), number of puffs of rescue medication (salbutamol), adverse events, pulse rate, systolic and diastolic blood pressure
| Estimated Enrollment: | 456 |
| Estimated Study Completion Date: | April 2006 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosis of COPD and diagnosis of asthma before the age of 30
- Current or ex-smokers with a cigarette smoking history of at least 10 pack-years
- Treatment with inhaled steroids at least 1 year before study entry
- FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
- FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years
- Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1
- Post bronchodilator FEV1 less than 70% of FVC at visit 1
Exclusion criteria:
- Respiratory infection or exacerbation 6 weeks prior to Visit 1 or during run-in period.
- Significant diseases other than COPD or asthma
- Myocardial infarction within the last 6 months
- Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
- Hospitalisation for heart failure (NYHA Class III or IV) within the last year
- History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
- Known active tuberculosis
- History of thoracotomy with pulmonary resection
- History of cancer within the last 5 years (excluding treated basal cell carcinoma)
- Patients requiring oxygen therapy for more than 1 hour per day
- Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1
- Known hypersensitivity to anticholinergic drugs or lactose
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152984
Show 68 Study Locations
Show 68 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00152984 History of Changes |
| Other Study ID Numbers: | 205.301 |
| Study First Received: | September 8, 2005 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment France: National Consultative Ethics Committee for Health and Life Sciences Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte South Africa: Medicines Control Council Denmark: Danish Medicines Agency Canada: Health Canada Italy: Ministry of Health Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Asthma Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Disease Attributes Pathologic Processes |
Tiotropium Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013