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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: April 30, 2014
Last verified: April 2014
  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: 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 ]

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 ]
  • 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 ]
  • FEV1, FVC AUC0-3h and peak response after 0, 4, 12, and 24 weeks [ Time Frame: after 0, 4, 12, and 24 weeks ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: 24 weeks ]
  • 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 ]
  • Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate) [ Time Frame: 24 weeks ]
  • Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol [salbuterol]) [ Time Frame: 24 weeks ]
  • Physician's Global Evaluation [ Time Frame: 24 weeks ]
  • Patient questionnaires: two Mahler Dyspnea Indices; St. George's Respiratory Questionnaire (SGRQ); and the SF-36 questionnaire [ Time Frame: 24 weeks ]
  • Number of patients with at least one COPD exacerbation [ Time Frame: 24 weeks ]
  • Time to first exacerbation, as well as number of COPD exacerbations [ Time Frame: 24 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00528996

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

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: April 30, 2014

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017