Dose Finding Study in COPD

NCT00122434 | Completed Phase 2

• 1 other identifier: 1205.4
• Study Type: interventional
• Target: 389
• Locations: 3 countries
• Sites: 43

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Trough forced expiratory volume (FEV1) response after four weeks of treatment.

  4 weeks

Secondary Outcomes (13)

• 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

Interventions

BEA 2180 BR DRUG

tiotropium DRUG

Eligibility Criteria

• Age: 40 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (43)

UAB Lung Health Center

Birmingham, Alabama, United States

Location

Vapahcs 111P

Palo Alto, California, United States

Location

Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

GLAHS Sepulveda

Sepulveda, California, United States

Location

Rehabilitation Clinical Trial Center

Torrance, California, United States

Location

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

Hospital for Special Care

New Britain, Connecticut, United States

Location

Bay Pines VA Medical Center

Bay Pines, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

LSUHSC - Shreveport

Shreveport, Louisiana, United States

Location

VAMC-Reno

Reno, Nevada, United States

Location

North Shore Universtiy Hospital

New Hyde Park, New York, United States

Location

SVMMC

Toledo, Ohio, United States

Location

Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, United States

Location

Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

Frank Sciurba

Pittsburgh, Pennsylvania, United States

Location

Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

MUSC

Charleston, South Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Harker Heights, Texas, United States

Location

MEDVAMC

Houston, Texas, United States

Location

McGuire VA

Fredericksburg, Virginia, United States

Location

Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

CHU du Sart Tilman (B35)

Angleur, Belgium

Location

A.Z. VUB

Brussels, Belgium

Location

UZ Antwerpen

Edegem, Belgium

Location

AZ Jan Palfijn

Ghent, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Virga Jesseziekenhuis

Hasselt, Belgium

Location

Clinique Reine Astrid

Malmedy, Belgium

Location

Heilig Hartziekenhuis

Menen, Belgium

Location

Sint-Elisabethziekenhuis

Turnhout, Belgium

Location

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Tjongerschans Ziekenhuis

Heerenveen, Netherlands

Location

Atrium Medisch Centrum

Heerlen, Netherlands

Location

Ziekenhuisgroep Twente

Hengelo, Netherlands

Location

Academisch Ziekenhuis Nijmegen St. Radbout

Nijmegen, Netherlands

Location

Gelre Ziekenhuizen

Zutphen, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Boehringer Ingelheim Study Coordinator

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2005
• First Posted: July 22, 2005
• Study Start: July 1, 2005
• Primary Completion: May 1, 2006
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

US (27); BE (9); NL (7)