Dose Finding Study in COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00122434
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 389
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Trough forced expiratory volume (FEV1) response after four weeks of treatment. 4 weeks
- Secondary Outcome Measures
Name Time Method drug urine concentrations 4 or 7 weeks Trough FEV1 response after 1 and 2 weeks after 1 and 2 weeks Trough FVC response after 1, 2 and 4 weeks after 1, 2 and 4 weeks FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks after 0, 1, 2 and 4 weeks Individual FEV1 and FVC measurements at each time point 4 weeks Weekly mean pre-dose morning and evening PEFR 4 weeks Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] 4 weeks COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) 4 weeks Physician's Global Evaluation 4 weeks All adverse events 7 weeks Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT) 4 weeks 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5) 4 weeks drug plasma concentrations 4 or 7 weeks
Trial Locations
- Locations (31)
McGuire VA
🇺🇸Fredericksburg, Virginia, United States
Academisch Ziekenhuis Nijmegen St. Radbout
🇳🇱Nijmegen, Netherlands
Gelre Ziekenhuizen
🇳🇱Zutphen, Netherlands
Hospital for Special Care
🇺🇸New Britain, Connecticut, United States
LSUHSC - Shreveport
🇺🇸Shreveport, Louisiana, United States
VAMC-Reno
🇺🇸Reno, Nevada, United States
Rehabilitation Clinical Trial Center
🇺🇸Torrance, California, United States
North Shore Universtiy Hospital
🇺🇸New Hyde Park, New York, United States
SVMMC
🇺🇸Toledo, Ohio, United States
CHU du Sart Tilman (B35)
🇧🇪Angleur, Belgium
Frank Sciurba
🇺🇸Pittsburgh, Pennsylvania, United States
AZ Jan Palfijn
🇧🇪Gent, Belgium
Heilig Hartziekenhuis
🇧🇪Menen, Belgium
Sint-Elisabethziekenhuis
🇧🇪Turnhout, Belgium
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
A.Z. VUB
🇧🇪Brussel, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
Virga Jesseziekenhuis
🇧🇪Hasselt, Belgium
Ziekenhuisgroep Twente
🇳🇱Hengelo, Netherlands
Tjongerschans Ziekenhuis
🇳🇱Heerenveen, Netherlands
Atrium Medisch Centrum
🇳🇱Heerlen, Netherlands
Vapahcs 111P
🇺🇸Palo Alto, California, United States
Bay Pines VA Medical Center
🇺🇸Bay Pines, Florida, United States
Boehringer Ingelheim Investigational Site
🇺🇸Tacoma, Washington, United States
GLAHS Sepulveda
🇺🇸Sepulveda, California, United States
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
MEDVAMC
🇺🇸Houston, Texas, United States
Clinique Reine Astrid
🇧🇪Malmedy, Belgium
UAB Lung Health Center
🇺🇸Birmingham, Alabama, United States
MUSC
🇺🇸Charleston, South Carolina, United States