Tiotropium/Salmeterol Inhalation Powder in COPD - Full Text View

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 bt the SGRQ and the effect on COPD exacerbations

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Tiotropium/Salmeterol Drug: Tiotropium/Salmeterol QD + Salmeterol Drug: Placebo Drug: Salmeterol Drug: Tiotropium	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Polyethylene Salmeterol Salmeterol xinafoate Tiotropium bromide

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Trough FEV1 response [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
FEV1AUC 0 8hr response [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
Mahler TDI focal score [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
SGRQ total score [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
Time to first moderate to severe COPD exacerbation [ Time Frame: 12 Weeks, 24 Weeks and 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Trough FVC response [ Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
FVCAUC 0 8h response [ Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
PEF [ Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
Use of rescue medication [ Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks ] [ Designated as safety issue: No ]
COPD related night time awakenings [ Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks ] [ Designated as safety issue: No ]

Enrollment:	207
Study Start Date:	April 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tiotropium/Salmeterol QD Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule	Drug: Tiotropium/Salmeterol Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule
Active Comparator: Tiotropium QD Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)	Drug: Tiotropium Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)
Active Comparator: Salmeterol BID Salmeterol Inhalation Powder, hard PE capsule	Drug: Salmeterol Salmeterol Inhalation Powder, hard PE capsule
Active Comparator: Tiotropium/Salmeterol QD + Salmeterol Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule	Drug: Tiotropium/Salmeterol QD + Salmeterol Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule
Placebo Comparator: Placebo Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule	Drug: Placebo Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

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 Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year Hospitalisation for cardiac failure during the past year History of asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668772

Show 64 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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00668772 History of Changes
Other Study ID Numbers:	1184.15, 2007-005107-17
Study First Received:	April 17, 2008
Last Updated:	July 14, 2011
Health Authority:	Austria: Federal Office for Safety in Health Care Canada: Therapeutic Products Directorate Denmark: The Danish Medicines Agency Estonia: State Agency of Medicines, EE-5041Tartu Finland: Finnish Medicines Agency France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy, H-1051 Budapest Italy: Ethics Committee 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: Central Committee on Research Involving Human Subjects (CCMO) Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 South Africa: Medicines Control Council Sweden: Medical Products Agency Regional Ethics Committee of Lund United States: Food and Drug Administration

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Salmeterol
Albuterol
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 16, 2013