Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00877383

Purpose

This study will assess efficacy and safety of indacaterol (150 µg once daily [o.d.]) when combined with tiotropium (18 µg o.d.) versus tiotropium (18 µg o.d.) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Tiotropium (18 µg) + indacaterol (150 µg) Drug: Tiotropium (18 µg)	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Tiotropium Indacaterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	A Randomized, Double-Blind, Controlled, Parallel Group, 12-Week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Further study details as provided by Novartis:

Primary Outcome Measures:

Standardized area under the curve (AUC) for forced expiratory volume in 1 second (FEV1) between 5 min - 8 h post-dose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Trough FEV1 24h post-dose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
FEV1 AUC 5 min - 8 h [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
FEV1 AUC 5 min - 4 h [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
FEV1 AUC 5 min - 4 h [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Trough FEV1 [ Time Frame: After 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	1126
Study Start Date:	April 2009
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tiotropium (18 µg) + indacaterol (150 µg): Experimental Tiotropium (18 µg) once daily + indacaterol (150 µg) once daily	Drug: Tiotropium (18 µg) + indacaterol (150 µg) Once daily via single-dose dry powder inhalers
Tiotropium (18 µg) + placebo to indacaterol: Active Comparator Tiotropium (18 µg) once daily + placebo to indacaterol once daily	Drug: Tiotropium (18 µg) Once daily via dry powder inhaler

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- Smoking history of at least 10 pack-years
- Post-bronchodilator FEV1 ≤65% and ≥30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

Patients who have received systemic corticosteroids and/or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877383

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Show 142 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceticals

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CQAB149B2351
Study First Received:	April 6, 2009
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00877383 History of Changes
Health Authority:	United States: Food and Drug Administration; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Slovakia: State Institute for Drug Control; Canada: Health Canada

Keywords provided by Novartis:

Chronic obstructive pulmonary disease
COPD
indacaterol
tiotropium
bronchodilation

Study placed in the following topic categories:

Neurotransmitter Agents
Lung Diseases, Obstructive
Cholinergic Antagonists
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Anti-Asthmatic Agents
Peripheral Nervous System Agents
Cholinergic Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions

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

ClinicalTrials.gov processed this record on May 07, 2009