Dose Finding Study in COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00122434
First received: July 18, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Multiple-dose, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Study to Determine the Optimum Dose of BEA 2180 BR Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough forced expiratory volume (FEV1) response after four weeks of treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FEV1 response after 1 and 2 weeks [ Time Frame: after 1 and 2 weeks ] [ Designated as safety issue: No ]
  • Trough FVC response after 1, 2 and 4 weeks [ Time Frame: after 1, 2 and 4 weeks ] [ Designated as safety issue: No ]
  • FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks [ Time Frame: after 0, 1, 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pre-dose morning and evening PEFR [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Evaluation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • drug plasma concentrations [ Time Frame: 4 or 7 weeks ] [ Designated as safety issue: No ]
  • drug urine concentrations [ Time Frame: 4 or 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 389
Study Start Date: July 2005
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 83 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 >=30% and <= 60% of predicted normal and FEV1 <=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
  2. All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
  3. Male or female patients 40 years of age or older.
  4. Smoker or ex-smoker with a history of more than 10 pack years.

1. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.

  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: NCT00122434

  Show 43 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Investigator: Boehringer Ingelheim Study Coordinator
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00122434     History of Changes
Other Study ID Numbers: 1205.4
Study First Received: July 18, 2005
Last Updated: October 28, 2013
Health Authority: 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 July 26, 2014