Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)
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Purpose
The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: olodaterol (BI 1744) low and placebo Drug: olodaterol (BI 1744) low and low tio Drug: olodaterol (BI 1744) high and placebo Drug: olodaterol (BI 1744) low and medium tio Drug: olodaterol (BI 1744) low and high tio Drug: olodaterol (BI 1744) high and low tio Drug: olodaterol (BI 1744) high and medium tio Drug: olodaterol (B( 1744) high and high tio |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, 8 Treatments, 4 Periods, Incomplete Crossover Study to Determine the Optimal Free Dose Combination of BI 1744 CL and Tiotropium Bromide (Both Delivered by the Respimat® Inhaler) After 4 Weeks Once Daily Treatment in Patients With COPD |
- The primary endpoint is the trough FEV1 response (L) after four weeks of treatment. [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]
- Trough FVC (forced vital capacity) response (L) after 4 weeks of treatment [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
- FEV1, FVC and PEF AUC 0-3h, AUC 0-6h and peak 0-3h response (L) after 4 weeks of treatment [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
- FEV1, FVC and PEF AUC 0-3h and peak 0-3h response (L) after the first dose. [ Time Frame: after first dose ] [ Designated as safety issue: No ]
- Individual FEV1, FVC and PEF measurements (L) at each time point [ Time Frame: on treatment ] [ Designated as safety issue: No ]
- Weekly mean number of puffs of rescue medication used per day (PRN salbutamol (albuterol)) [ Time Frame: on treatment ] [ Designated as safety issue: No ]
- Physicians Global Evaluation [ Time Frame: study start until follow up ] [ Designated as safety issue: No ]
- Patients Global Rating [ Time Frame: on treatment ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: study start until follow up ] [ Designated as safety issue: Yes ]
- Pulse rate and blood pressure (seated) recorded in conjunction with spirometry (30 minutes post dose only) [ Time Frame: study start until follow up ] [ Designated as safety issue: Yes ]
| Enrollment: | 233 |
| Study Start Date: | January 2010 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: olodaterol (BI 1744) low and placebo
low dose inhaled olodaterol orally once daily from the Respimat inhaler
|
Drug: olodaterol (BI 1744) low and placebo
comparison of different dosages of drug combination
|
|
Experimental: olodaterol (BI 1744) low and low tio
low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily
|
Drug: olodaterol (BI 1744) low and low tio
comparison of different dosages of drug combination
|
|
Experimental: olodaterol (BI 1744) low and medium tio
low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily
|
Drug: olodaterol (BI 1744) low and medium tio
comparison of different dosages of dose combination
|
|
Experimental: olodaterol (BI 1744) low and high tio
low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
|
Drug: olodaterol (BI 1744) low and high tio
comparison of different dosages of drug combination
|
|
Experimental: olodaterol (BI 1744) high and placebo
high dose inhaled olodaterol orally once daily from the Respimat inhaler
|
Drug: olodaterol (BI 1744) high and placebo
comparison of different dosages of drug combination
|
|
Experimental: Olodaterol (BI 1744) high and low tio
high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily
|
Drug: olodaterol (BI 1744) high and low tio
comparison of different dosages of drug combination
|
|
Experimental: Olodaterol (BI 1744) high and medium tio
high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily
|
Drug: olodaterol (BI 1744) high and medium tio
comparison of different dosages of drug combination
|
|
Experimental: Olodaterol (BI 1744) high and high tio
high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
|
Drug: olodaterol (B( 1744) high and high tio
comparison of different dosages of drug combination
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- All patients must sign an informed consent
- All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:
a post-bronchodilator forced expiratory flow in 1 second (FEV1) =<30% of predicted normal and <80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) <70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years
Exclusion criteria:
- Patients with a significant disease other than COPD;
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- Patients with a history of asthma or a total blood eosinophil count >=600/mm3.
- Patients with any of the following conditions:
a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- Patients who have undergone thoracotomy with pulmonary resection
- Patients being treated with the following concomitant medications:
medications that prolong the QT/QTc interval oral Beta-adrenergics oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- Pregnant or nursing women
Contacts and Locations| Canada, British Columbia | |
| 1237.18.02004 Boehringer Ingelheim Investigational Site | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| 1237.18.02005 Boehringer Ingelheim Investigational Site | |
| Grimsby, Ontario, Canada | |
| 1237.18.02001 Boehringer Ingelheim Investigational Site | |
| Mississauga, Ontario, Canada | |
| 1237.18.02008 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| 1237.18.02002 Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| 1237.18.02003 Boehringer Ingelheim Investigational Site | |
| Point Claire, Quebec, Canada | |
| 1237.18.02007 Boehringer Ingelheim Investigational Site | |
| Sherbrooke, Quebec, Canada | |
| Canada, Saskatchewan | |
| 1237.18.02011 Boehringer Ingelheim Investigational Site | |
| Saskatoon, Saskatchewan, Canada | |
| Canada | |
| 1237.18.02009 Boehringer Ingelheim Investigational Site | |
| Quebec, Canada | |
| Germany | |
| 1237.18.49009 Boehringer Ingelheim Investigational Site | |
| Aschaffenburg, Germany | |
| 1237.18.49012 Boehringer Ingelheim Investigational Site | |
| Bamberg, Germany | |
| 1237.18.49005 Boehringer Ingelheim Investigational Site | |
| Berlin, Germany | |
| 1237.18.49004 Boehringer Ingelheim Investigational Site | |
| Frankfurt, Germany | |
| 1237.18.49011 Boehringer Ingelheim Investigational Site | |
| Hamburg, Germany | |
| 1237.18.49010 Boehringer Ingelheim Investigational Site | |
| Koblenz, Germany | |
| 1237.18.49007 Boehringer Ingelheim Investigational Site | |
| Mannheim, Germany | |
| 1237.18.49001 Boehringer Ingelheim Investigational Site | |
| Potsdam, Germany | |
| 1237.18.49006 Boehringer Ingelheim Investigational Site | |
| Rodgau-Dudenhofen, Germany | |
| 1237.18.49002 Boehringer Ingelheim Investigational Site | |
| Rüdersdorf, Germany | |
| 1237.18.49003 Boehringer Ingelheim Investigational Site | |
| Weinheim, Germany | |
| 1237.18.49008 Boehringer Ingelheim Investigational Site | |
| Wiesloch, Germany | |
| Netherlands | |
| 1237.18.31004 Boehringer Ingelheim Investigational Site | |
| Almelo, Netherlands | |
| 1237.18.31006 Boehringer Ingelheim Investigational Site | |
| Amsterdam, Netherlands | |
| 1237.18.31008 Boehringer Ingelheim Investigational Site | |
| Eindhoven, Netherlands | |
| 1237.18.31001 Boehringer Ingelheim Investigational Site | |
| Groningen, Netherlands | |
| 1237.18.31007 Boehringer Ingelheim Investigational Site | |
| Hengelo, Netherlands | |
| 1237.18.31005 Boehringer Ingelheim Investigational Site | |
| Hoorn, Netherlands | |
| 1237.18.31002 Boehringer Ingelheim Investigational Site | |
| Veldhoven, Netherlands | |
| 1237.18.31003 Boehringer Ingelheim Investigational Site | |
| Zutphen, Netherlands | |
| Sweden | |
| 1237.18.46003 Boehringer Ingelheim Investigational Site | |
| Boden, Sweden | |
| 1237.18.46002 Boehringer Ingelheim Investigational Site | |
| Göteborg, Sweden | |
| 1237.18.46001 Boehringer Ingelheim Investigational Site | |
| Lund, Sweden | |
| 1237.18.46004 Boehringer Ingelheim Investigational Site | |
| Stockholm, Sweden | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01040403 History of Changes |
| Other Study ID Numbers: | 1237.18, 2009-014880-38 |
| Study First Received: | December 28, 2009 |
| Last Updated: | June 1, 2011 |
| Health Authority: | Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Netherlands: Central Committee Research Involving Human Subjects Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases 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