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: Salmeterol Salmeterol xinafoate Tiotropium bromide Tiotropium

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 ]

Enrollment:	220
Study Start Date:	April 2008
Primary Completion Date:	November 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:

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

Exclusion Criteria:

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 72 Study Locations

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:	1184.14, EudraCT 2007-005134-36
Study First Received:	April 17, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00662740 History of Changes
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 Agency for Medicines; France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines (EOF) National Ethics Committee; Hungary: National Institute of Pharmacy, H-1051 Budapest; Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa; Korea, Republic of: Korea Food and Drug Administration; Latvia: State Agency of Medicines, LV-1003 Riga; Lithuania: State Medicines Control Agency, LT-01132 Vilnius; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Sweden: Medical Products Agency Regional Ethics Committee of Lund; United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Salmeterol
Cholinergic Antagonists
Adrenergic Agents
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Disease Attributes
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

Therapeutic Uses
Tiotropium
Salmeterol
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009