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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

July 18, 2005
October 28, 2013
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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: BEA 2180 BR
  • Drug: tiotropium
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
389
Not Provided
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.

Both
40 Years to 83 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Netherlands
 
NCT00122434
1205.4
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Investigator: Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
October 2013

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