Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01040403
First received: December 28, 2009
Last updated: March 28, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion criteria:

  1. All patients must sign an informed consent
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040403

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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  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: March 28, 2014
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014