Clinical trial NCT00122434: Dose Finding Study in COPD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-07-22
Enrollment: 389
Sex: ALL
Minimum age (years): 40
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Trough forced expiratory volume (FEV1) response after four weeks of treatment.
timeFrame: 4 weeks
Secondary outcomes:
measure: Trough FEV1 response after 1 and 2 weeks
timeFrame: after 1 and 2 weeks
measure: Trough FVC response after 1, 2 and 4 weeks
timeFrame: after 1, 2 and 4 weeks
measure: FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks
timeFrame: after 0, 1, 2 and 4 weeks
measure: Individual FEV1 and FVC measurements at each time point
timeFrame: 4 weeks
measure: Weekly mean pre-dose morning and evening PEFR
timeFrame: 4 weeks
measure: Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]
timeFrame: 4 weeks
measure: COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
timeFrame: 4 weeks
measure: Physician's Global Evaluation
timeFrame: 4 weeks
measure: All adverse events
timeFrame: 7 weeks
measure: Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)
timeFrame: 4 weeks
measure: 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)
timeFrame: 4 weeks
measure: drug plasma concentrations
timeFrame: 4 or 7 weeks
measure: drug urine concentrations
timeFrame: 4 or 7 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lung Health Center
state: Alabama
city: Palo Alto
country: United States
facility: Vapahcs 111P
state: California
city: San Diego
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Sepulveda
country: United States
facility: GLAHS Sepulveda
state: California
city: Torrance
country: United States
facility: Rehabilitation Clinical Trial Center
state: California
city: Wheat Ridge
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: New Britain
country: United States
facility: Hospital for Special Care
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Medical Center
state: Florida
city: Panama City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Idaho
city: Shreveport
country: United States
facility: LSUHSC - Shreveport
state: Louisiana
city: Reno
country: United States
facility: VAMC-Reno
state: Nevada
city: New Hyde Park
country: United States
facility: North Shore Universtiy Hospital
state: New York
city: Toledo
country: United States
facility: SVMMC
state: Ohio
city: Medford
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Oregon
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Frank Sciurba
state: Pennsylvania
city: Charleston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Spartanburg
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Harker Heights
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: MEDVAMC
state: Texas
city: Fredericksburg
country: United States
facility: McGuire VA
state: Virginia
city: Richmond
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Angleur
country: Belgium
facility: CHU du Sart Tilman (B35)
city: Brussel
country: Belgium
facility: A.Z. VUB
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: AZ Jan Palfijn
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Virga Jesseziekenhuis
city: Malmedy
country: Belgium
facility: Clinique Reine Astrid
city: Menen
country: Belgium
facility: Heilig Hartziekenhuis
city: Turnhout
country: Belgium
facility: Sint-Elisabethziekenhuis
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Heerenveen
country: Netherlands
facility: Tjongerschans Ziekenhuis
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Nijmegen
country: Netherlands
facility: Academisch Ziekenhuis Nijmegen St. Radbout
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen
Study officials:
name: Boehringer Ingelheim Study Coordinator
References: