Tiotropium/Salmeterol Inhalation Powder in COPD - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00662740

Purpose

The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined by the SGRQ and the effect on COPD exacerbations.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Tiotropium/Salmeterol Drug: Tiotropium Drug: Salmeterol	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium Tiotropium bromide Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Parallel Assignment, Safety/Efficacy Study
Official Title:	1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Trough FEV1 response FEV1AUC 0 8h response Mahler TDI focal score SGRQ total score Time to first moderate to severe COPD exacerbation [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ]

Secondary Outcome Measures:

Trough FVC response FVCAUC 0 8h response PEF use of rescue medication COPD related night time awakenings [ Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks ]

Estimated Enrollment:	220
Study Start Date:	April 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Main:

Diagnosis of COPD Post-bronchodilator FEV1<80% predicted and FEV1/FVC<70% predicted

Exclusion Criteria:

Main:

Significant other diseases then COPD Recent MI Unstable or life-threatening arrythmia requiring intervention or change in drug therapy Hospitalisation for cardiac failure in past year History of asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662740

Show 74 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:	1184.14, EudraCT 2007-005134-36
Study First Received:	April 17, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00662740
Health Authority:	Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicines and Health Products Canada: Therapeutic Products Directorate Denmark: The Danish Medicines Agency Estonia: State Agency of Medicines, EE-5041Tartu Finland: National Ag

Study placed in the following topic categories:

Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases
Lung Diseases

Chronic Disease
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Disease Attributes
Neurotransmitter Agents
Cholinergic Antagonists
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009