Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD). - Full Text View

Sponsored by:	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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium Tiotropium bromide Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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

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:	December 2009 (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

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Show 53 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

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:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00523991
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: INFARMED - National Authority of Medicines and Health Products, IP; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Albuterol

Respiration Disorders
Chronic Disease
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Disease Attributes
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009