The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solution delivered by the Respimat ® inhaler once daily for four weeks in patients with COPD.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: BEA 2180 BR  Drug: tiotropium	Phase II

Further Study Details: 

Primary Outcomes: 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
Secondary Outcomes: 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
Expected Total Enrollment:  420

Ages Eligible for Study:  40 Years   -   80 Years,  Genders Eligible for Study:  Both

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 (the -10 minute measurement) 45 min after inhalation of 80 µg 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. 5. Patients with any other significant disease will be excluded. 6. Patients with a history of asthma or allergic rhinitis will be excluded.

Please refer to this study by ClinicalTrials.gov identifier  NCT00122434

Elizabeth Joseph, Ms.      203-798-4406    ejoseph@rdg.boehringer-ingelheim.com

Alabama
      UAB Lung Health Center, Birmingham,  Alabama,  United States
California
      Institute of Health Care Assessment, San Diego,  California,  United States
      Vapahcs 111P, Palo Alto,  California,  United States
      GLAHS Sepulveda, Sepulveda,  California,  United States
      Rehabilitation Clinical Trial Center, Torrance,  California,  United States
Colorado
      Rocky Mountain Center for Clinical Research, Wheat Ridge,  Colorado,  United States
      Western States Clinical Research, Wheat Ridge,  Colorado,  United States
Connecticut
      Hospital for Special Care, New Britain,  Connecticut,  United States
Florida
      10000 Bay PInes Blvd, Bay Pines,  Florida,  United States
      Panama City,  Florida,  United States
      Pembroke Pines,  Florida,  United States
Idaho
      Pulmonary Consultants of North Idaho, Coeur D Alene,  Idaho,  United States
Louisiana
      LSUHSC - Shreveport, Shreveport,  Louisiana,  United States
Nevada
      Reno,  Nevada,  United States
New York
      New Hyde Park,  New York,  United States
Ohio
      SVMMC, Toledo,  Ohio,  United States
Oregon
      Medford,  Oregon,  United States
Pennsylvania
      Peter Arcuri, DO, Philadelphia,  Pennsylvania,  United States
      Hershey Medical Center, Hershey,  Pennsylvania,  United States
      Pittsburgh,  Pennsylvania,  United States
South Carolina
      Spartanburg,  South Carolina,  United States
      Attention: Thomas D. Kaelin, Jr., D.O., Charleston,  South Carolina,  United States
      MUSC, Charleston,  South Carolina,  United States
Texas
      MEDVAMC, Houston,  Texas,  United States
      Team Research of Texas, Harker Heights,  Texas,  United States
Virginia
      Omer Abdullah, MD, Fredericksburg,  Virginia,  United States
Washington
      Pulmonary Consultants, Tacoma,  Washington,  United States
Belgium
      CHU du Sart Tilman (B35), Angleur,  Belgium
      Virga Jesseziekenhuis, Hasselt,  Belgium
      Heilig Hartziekenhuis, Menen,  Belgium
      UZ Antwerpen, Edegem,  Belgium
      Clinique Reine Astrid, Malmedy,  Belgium
      Sint-Elisabethziekenhuis, TURNHOUT,  Belgium
      AZ Jan Palfijn, Gent,  Belgium
      Ziekenhuis Oost-Limburg, Lanaken,  Belgium
      UZ Gent, Gent,  Belgium
      a.Z. VUB, Brussel,  Belgium
Netherlands
      Lokatie Langendijk, Breda,  Netherlands
      Polikliniek Inwendige ziekten, Nijmegen,  Netherlands
      Lokatie Het Spittaal, Zutphen,  Netherlands
      Polikliniek longziekten, HEERLEN,  Netherlands
      Lokatie Twenteborg, Almelo,  Netherlands
      Polikliniek longziekten, Hengelo,  Netherlands
      Polikliniek longziekten, Heerenveen,  Netherlands

Study chairs or principal investigators

Elizabeth Joseph, Ms.

Study ID Numbers:  1205.4
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122434
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26