An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00528996
First received: September 12, 2007
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: BEA 2180 BR
Drug: tiotropium
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Multinational, Randomised, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint in this study is trough FEV1 response after 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FEV1 response after 1, 2, 4, 8, 12, and 18 weeks [ Time Frame: after 1, 2, 4, 8, 12, and 18 weeks ] [ Designated as safety issue: No ]
  • Trough FVC (forced vital capacity) response after 1, 2, 4, 8, 12, 18, and 24 weeks [ Time Frame: after 1, 2, 4, 8, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]
  • FEV1, FVC AUC0-3h and peak response after 0, 4, 12, and 24 weeks [ Time Frame: after 0, 4, 12, and 24 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • trough FEV1 response on Days 3 and 5 and FEV1 and FVC at 3 minutes and 10 minutes following drug administration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol [salbuterol]) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient questionnaires: two Mahler Dyspnea Indices; St. George's Respiratory Questionnaire (SGRQ); and the SF-36 questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of patients with at least one COPD exacerbation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to first exacerbation, as well as number of COPD exacerbations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 2080
Study Start Date: September 2007
Primary Completion Date: May 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 (P95 4381) and must meet the following spirometric criteria:

    Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) <80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).

  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. Patients who have never smoked cigarettes must be excluded.
  5. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily 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 (Appendix I)

Exclusion Criteria:

  1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
  2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
  3. Patients with a recent history (one year or less) of myocardial infarction.
  4. Patients with any unstable or life-threatening cardiac arrhythmia.
  5. Patients who have been hospitalized for heart failure within the past 3 years.
  6. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
  7. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
  8. Patients with known narrow-angle glaucoma.
  9. Patients with asthma or a history of asthma.
  10. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
  11. Patients with known active tuberculosis.
  12. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528996

  Show 178 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00528996     History of Changes
Other Study ID Numbers: 1205.14, 2007-007946-42
Study First Received: September 12, 2007
Last Updated: July 31, 2013
Health Authority: Canada: Therapeutic Products Directorate branch of Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest
Korea, Republic of: KOREA Food and Drug Administration (KFDA)
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Poland: CEBK, Warsaw
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Spain: Spanish Medicines and Healthcare Products Agency
Taiwan: Department of Health, Executive Yuan, Taiwan
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
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 April 23, 2014