Dose Finding Study in COPD

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. Identifier: NCT00122434
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : December 28, 2017
Information provided by:
Boehringer Ingelheim

July 18, 2005
July 22, 2005
December 28, 2017
July 2005
May 2006   (Final data collection date for primary outcome measure)
Trough forced expiratory volume (FEV1) response after four weeks of treatment. [ Time Frame: 4 weeks ]
The primary endpoint is trough FEV1 response determined at the end of the four-week treatment period. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing
Complete list of historical versions of study NCT00122434 on Archive Site
  • 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 ]
  • 1.Trough FEV1 response after 1 and 2 weeks
  • 2.Trough FVC response after 1, 2, and 4 weeks
  • 3.FEV1 and FVC AUC0-6h and peak response after 0, 1, 2, and 4 weeks
  • 4.Individual FEV1 and FVC measurements at each time point
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Dose Finding Study in COPD
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)
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: BEA 2180 BR
  • Drug: tiotropium
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2006   (Final data collection date for primary outcome measure)
  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.

Sexes Eligible for Study: All
40 Years to 83 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands,   United States
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Boehringer Ingelheim
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Investigator: Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP