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Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, November 2009
First Received: July 9, 2007   Last Updated: November 23, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00523991
  Purpose

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus PRN albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium inhalation capsules
Phase IV

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is improvement in lung function as measured by the forced expiratory volume in 1 second (FEV1) AUC0 3h post dose response at week 24 (end of study). [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • FEV1 and FVC parameters Physical activity and energy expenditure as determined by the activity monitor Physician´s and patient global assessments Work productivity Use of rescue medication prn albuterol (salbutamol) [ Time Frame: 24 weeks ]

Estimated Enrollment: 436
Study Start Date: April 2007
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects must have a diagnosis of COPD according to GOLD guideline criteria:
  • post-bronchodilator FEV1/FVC ratio < 70% (visit 1).
  • Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1).
  • Subjects must be current or ex-smokers with a smoking history of >=10 pack years.
  • Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

Exclusion Criteria:

  • Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.
  • Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.
  • Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3
  • Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523991

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
United States, Alabama
205.365.1003 Boehringer Ingelheim Investigational Site Completed
Birmingham, Alabama, United States
205.365.1004 Boehringer Ingelheim Investigational Site Completed
Birmingham, Alabama, United States
205.365.1098 Boehringer Ingelheim Investigational Site Recruiting
Jasper, Alabama, United States
United States, California
205.365.1023 Boehringer Ingelheim Investigational Site Completed
Palo Alto, California, United States
205.365.1125 Boehringer Ingelheim Investigational Site Recruiting
San Diego, California, United States
United States, Florida
205.365.1101 Boehringer Ingelheim Investigational Site Recruiting
Chiefland, Florida, United States
205.365.1102 Boehringer Ingelheim Investigational Site Recruiting
Spring Hill, Florida, United States
United States, Kentucky
205.365.1024 Boehringer Ingelheim Investigational Site Recruiting
Lexington, Kentucky, United States
United States, Maryland
205.365.1012 Boehringer Ingelheim Investigational Site Recruiting
Baltimore, Maryland, United States
United States, Minnesota
205.365.1006 Boehringer Ingelheim Investigational Site Recruiting
Rochester, Minnesota, United States
205.365.1086 Boehringer Ingelheim Investigational Site Recruiting
Bloomington, Minnesota, United States
United States, Nebraska
205.365.1085 Boehringer Ingelheim Investigational Site Recruiting
Omaha, Nebraska, United States
United States, New Mexico
205.365.1010 Boehringer Ingelheim Investigational Site Completed
Albuquerque, New Mexico, United States
United States, New York
205.365.1007 Boehringer Ingelheim Investigational Site Recruiting
Rochester, New York, United States
United States, North Carolina
205.365.1080 Boehringer Ingelheim Investigational Site Recruiting
Charlotte, North Carolina, United States
United States, Ohio
205.365.1118 Boehringer Ingelheim Investigational Site Recruiting
Cincinnati, Ohio, United States
United States, Pennsylvania
205.365.1033 Boehringer Ingelheim Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States
United States, Tennessee
205.365.1092 Boehringer Ingelheim Investigational Site Recruiting
Kingsport, Tennessee, United States
United States, West Virginia
205.365.1122 Boehringer Ingelheim Investigational Site Recruiting
Clarksburg, West Virginia, United States
Belgium
205.365.1103 Boehringer Ingelheim Investigational Site Recruiting
Gilly, Belgium
205.365.1057 Boehringer Ingelheim Investigational Site Recruiting
Menen, Belgium
205.365.1058 Boehringer Ingelheim Investigational Site Recruiting
Yvoir, Belgium
205.365.1059 Boehringer Ingelheim Investigational Site Recruiting
Leuven, Belgium
Canada, British Columbia
205.365.1042 Boehringer Ingelheim Investigational Site Terminated
Vancouver, British Columbia, Canada
Canada, Ontario
205.365.1056 Boehringer Ingelheim Investigational Site Terminated
Kingston, Ontario, Canada
205.365.1104 Boehringer Ingelheim Investigational Site Recruiting
Toronto, Ontario, Canada
Canada, Quebec
205.365.1041 Boehringer Ingelheim Investigational Site Completed
Ste-Foy, Quebec, Canada
Czech Republic
205.365.1061 Boehringer Ingelheim Investigational Site Completed
Karlovy Vary, Czech Republic
205.365.1075 Boehringer Ingelheim Investigational Site Recruiting
Strakonice, Czech Republic
205.365.1079 Boehringer Ingelheim Investigational Site Terminated
Neratovice, Czech Republic
205.365.1077 Boehringer Ingelheim Investigational Site Recruiting
Liberec, Czech Republic
205.365.1062 Boehringer Ingelheim Investigational Site Recruiting
Praha 10, Czech Republic
205.365.1063 Boehringer Ingelheim Investigational Site Recruiting
Tabor, Czech Republic
205.365.1064 Boehringer Ingelheim Investigational Site Recruiting
Cvikov, Czech Republic
205.365.1076 Boehringer Ingelheim Investigational Site Recruiting
Usti Nad Labem, Czech Republic
205.365.1117 Boehringer Ingelheim Investigational Site Recruiting
Praha 6, Czech Republic
205.365.1107 Boehringer Ingelheim Investigational Site Recruiting
Hradec Kralove, Czech Republic
205.365.1116 Boehringer Ingelheim Investigational Site Recruiting
Pardubice, Czech Republic
205.365.1083 Boehringer Ingelheim Investigational Site Completed
Praha 3, Czech Republic
Germany
205.365.1050 Boehringer Ingelheim Investigational Site Recruiting
Ulm, Germany
205.365.1052 Boehringer Ingelheim Investigational Site Recruiting
Rüdersdorf, Germany
205.365.1054 Boehringer Ingelheim Investigational Site Completed
Gelnhausen, Germany
205.365.1055 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
205.365.1066 Boehringer Ingelheim Investigational Site Completed
Berlin, Germany
Greece
205.365.1067 Boehringer Ingelheim Investigational Site Recruiting
Athens, Greece
Netherlands
205.365.1069 Boehringer Ingelheim Investigational Site Recruiting
Zutphen, Netherlands
205.365.1070 Boehringer Ingelheim Investigational Site Recruiting
Enschede, Netherlands
205.365.1071 Boehringer Ingelheim Investigational Site Recruiting
Spijkenisse, Netherlands
205.365.1072 Boehringer Ingelheim Investigational Site Completed
Etten Leur, Netherlands
Portugal
205.365.1020 Boehringer Ingelheim Investigational Site Recruiting
Coimbra, Portugal
205.365.1022 Boehringer Ingelheim Investigational Site Recruiting
Lisboa, Portugal
205.365.1025 Boehringer Ingelheim Investigational Site Recruiting
Amadora, Portugal
Ukraine
205.365.1108 Boehringer Ingelheim Investigational Site Recruiting
Kharkov, Ukraine
205.365.1110 Boehringer Ingelheim Investigational Site Recruiting
Kharkiv, Ukraine
205.365.1112 Boehringer Ingelheim Investigational Site Recruiting
Kharkov, Ukraine
205.365.1113 Boehringer Ingelheim Investigational Site Recruiting
Simferopol, Ukraine
205.365.1114 Boehringer Ingelheim Investigational Site Recruiting
Kiev, Ukraine
205.365.1115 Boehringer Ingelheim Investigational Site Recruiting
Kiev, Ukraine
205.365.1128 Boehringer Ingelheim Investigational Site Recruiting
Dnipropetrovsk, Ukraine
United Kingdom
205.365.44004 Boehringer Ingelheim Investigational Site Terminated
Warminster, United Kingdom
205.365.44003 Boehringer Ingelheim Investigational Site Terminated
Harrow, United Kingdom
205.365.44002 Boehringer Ingelheim Investigational Site Recruiting
Garston, Watford, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 205.365, 2006-006276-38 A4471008
Study First Received: July 9, 2007
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00523991     History of Changes
Health Authority: Belgium: Federal Agency for Medicines and Health Products;   Canada: Health Canada - Therapeutic Products Directorate;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Germany: Federal Institute for Drugs and Medical Devices;   Great Britain: MHRA;   Greece: National Organization of Medicines (EOF);   Netherlands: Central Committee on Research involving Human Subjects (CCMO);   Portugal: National Pharmacy and Medicines Institute;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 25, 2009