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Dose Finding Study in COPD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00122434
First Posted: July 22, 2005
Last Update Posted: October 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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
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 ]

Secondary Outcome Measures:
  • Trough FEV1 response after 1 and 2 weeks [ Time Frame: after 1 and 2 weeks ]
  • Trough FVC response after 1, 2 and 4 weeks [ Time Frame: after 1, 2 and 4 weeks ]
  • FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks [ Time Frame: after 0, 1, 2 and 4 weeks ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: 4 weeks ]
  • Weekly mean pre-dose morning and evening PEFR [ Time Frame: 4 weeks ]
  • Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] [ Time Frame: 4 weeks ]
  • COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) [ Time Frame: 4 weeks ]
  • Physician's Global Evaluation [ Time Frame: 4 weeks ]
  • All adverse events [ Time Frame: 7 weeks ]
  • Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT) [ Time Frame: 4 weeks ]
  • 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 ]
  • drug plasma concentrations [ Time Frame: 4 or 7 weeks ]
  • drug urine concentrations [ Time Frame: 4 or 7 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 83 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122434


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

ClinicalTrials.gov Identifier: NCT00122434     History of Changes
Other Study ID Numbers: 1205.4
First Submitted: July 18, 2005
First Posted: July 22, 2005
Last Update Posted: October 29, 2013
Last Verified: October 2013

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