Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00720499
First received: July 21, 2008
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: BI1744/Tiotropium bromide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Cross-over Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 2 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination (FDC) With 5 Microgram Tiotropium Bromide (Delivered by the Respimat® Inhaler) in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary efficacy variable will be forced expiratory volume in one second (FEV1). The primary endpoint is the trough FEV1 response [L] after four weeks of treatment. [ Time Frame: 4 weeks of treatment ]

Secondary Outcome Measures:
  • FEV1 and FVC responses at different timepoints Weekly mean predose morning and evening PEF Weekly mean number of occations of rescue therapy used per day Patient's Global Rating scale Adverse events Laboratory and Vital signs [ Time Frame: up to 4 weeks of treatment ]

Enrollment: 141
Study Start Date: July 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
  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 consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
  2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:

    Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 >= 30% of predicted normal and <80% of predicted normal and a post-bronchodilator FEV1 / FVC <70% at Visit 1

  3. Male or female patients, 40 years of age or older
  4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years
  5. Patients must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
  6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).

Exclusion Criteria:

  1. Patients with a significant disease other than COPD
  2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
  3. Patients with a history of asthma or a total blood eosinophil count >= 600/mm3.
  4. Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF* interval > 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
  5. Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
  6. Patients who have undergone thoracotomy with pulmonary resection
  7. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
  8. Pregnant or nursing women
  9. Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
  10. Patients who have previously been randomized in this study or are currently participating in another study
  11. Patients who are unable to comply with pulmonary medication restrictions prior to randomization
  12. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
  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: NCT00720499

Locations
United States, Florida
1237.9.00152 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1237.9.00155 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Pennsylvania
1237.9.00151 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Texas
1237.9.00154 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
United States, Washington
1237.9.00153 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
Belgium
1237.9.03253 Boehringer Ingelheim Investigational Site
Brussel, Belgium
1237.9.03255 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1237.9.03254 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1237.9.03251 Boehringer Ingelheim Investigational Site
Gent, Belgium
1237.9.03252 Boehringer Ingelheim Investigational Site
Leuven, Belgium
Canada, Ontario
1237.9.00255 Boehringer Ingelheim Investigational Site
Mississauga, Ontario, Canada
1237.9.00251 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1237.9.00252 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1237.9.00254 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1237.9.00253 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec, Canada
Germany
1237.9.04954 Boehringer Ingelheim Investigational Site
Berlin, Germany
1237.9.04952 Boehringer Ingelheim Investigational Site
Berlin, Germany
1237.9.04953 Boehringer Ingelheim Investigational Site
Berlin, Germany
1237.9.04955 Boehringer Ingelheim Investigational Site
Bruchsal, Germany
1237.9.04959 Boehringer Ingelheim Investigational Site
Gelnhausen, Germany
1237.9.04960 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1237.9.04958 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1237.9.04951 Boehringer Ingelheim Investigational Site
Tübingen, Germany
1237.9.04956 Boehringer Ingelheim Investigational Site
Wiesloch, Germany
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: NCT00720499     History of Changes
Other Study ID Numbers: 1237.9, EudtaCT No: 2008-000562-23
Study First Received: July 21, 2008
Last Updated: March 28, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Bromides
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 22, 2014