Dose Finding Study in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122434
• Other study ID #: 1205.4
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2005
• Last updated: December 27, 2017
• Start date: July 2005

Study information

• Verified date: December 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 83 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BEA 2180 BR

• tiotropium

Locations

Country	Name	City	State
Belgium	CHU du Sart Tilman (B35)	Angleur
Belgium	A.Z. VUB	Brussel
Belgium	UZ Antwerpen	Edegem
Belgium	AZ Jan Palfijn	Gent
Belgium	UZ Gent	Gent
Belgium	Virga Jesseziekenhuis	Hasselt
Belgium	Clinique Reine Astrid	Malmedy
Belgium	Heilig Hartziekenhuis	Menen
Belgium	Sint-Elisabethziekenhuis	Turnhout
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Tjongerschans Ziekenhuis	Heerenveen
Netherlands	Atrium Medisch Centrum	Heerlen
Netherlands	Ziekenhuisgroep Twente	Hengelo
Netherlands	Academisch Ziekenhuis Nijmegen St. Radbout	Nijmegen
Netherlands	Gelre Ziekenhuizen	Zutphen
United States	Bay Pines VA Medical Center	Bay Pines	Florida
United States	UAB Lung Health Center	Birmingham	Alabama
United States	Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	MUSC	Charleston	South Carolina
United States	Boehringer Ingelheim Investigational Site	Coeur d'Alene	Idaho
United States	McGuire VA	Fredericksburg	Virginia
United States	Boehringer Ingelheim Investigational Site	Harker Heights	Texas
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	MEDVAMC	Houston	Texas
United States	Boehringer Ingelheim Investigational Site	Medford	Oregon
United States	Hospital for Special Care	New Britain	Connecticut
United States	North Shore Universtiy Hospital	New Hyde Park	New York
United States	Vapahcs 111P	Palo Alto	California
United States	Boehringer Ingelheim Investigational Site	Panama City	Florida
United States	Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	Frank Sciurba	Pittsburgh	Pennsylvania
United States	VAMC-Reno	Reno	Nevada
United States	Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	Boehringer Ingelheim Investigational Site	San Diego	California
United States	GLAHS Sepulveda	Sepulveda	California
United States	LSUHSC - Shreveport	Shreveport	Louisiana
United States	Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina
United States	Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	SVMMC	Toledo	Ohio
United States	Rehabilitation Clinical Trial Center	Torrance	California
United States	Boehringer Ingelheim Investigational Site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough forced expiratory volume (FEV1) response after four weeks of treatment.		4 weeks
Secondary	Trough FEV1 response after 1 and 2 weeks		after 1 and 2 weeks
Secondary	Trough FVC response after 1, 2 and 4 weeks		after 1, 2 and 4 weeks
Secondary	FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks		after 0, 1, 2 and 4 weeks
Secondary	Individual FEV1 and FVC measurements at each time point		4 weeks
Secondary	Weekly mean pre-dose morning and evening PEFR		4 weeks
Secondary	Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]		4 weeks
Secondary	COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)		4 weeks
Secondary	Physician's Global Evaluation		4 weeks
Secondary	All adverse events		7 weeks
Secondary	Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)		4 weeks
Secondary	12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)		4 weeks
Secondary	drug plasma concentrations		4 or 7 weeks
Secondary	drug urine concentrations		4 or 7 weeks

External Links

•   Link