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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: Indacaterol 150 μg (Drug); Tiotropium 18 μg (Drug); Placebo to indacaterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)

Secondary outcome:

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as

classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and: 1. Smoking history of at least 10 pack-years 2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value 3. Post-bronchodilator FEV1/FVC (force vital capacity) < 70% Exclusion Criteria:

- Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid

treatment or antibiotics and/or hospitalization 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

or during the run-in period

- Patients with a body mass index less than 15 or more than 40 kg/m^2

- 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 applied to the study.

Locations and Contacts

Novartis Investigative Site, Buenos Aires, Argentina

Novartis Investigative Site, Cordoba, Argentina

Novartis Investigative Site, Corrientes, Argentina

Novartis Investigative SIte, Mendoza, Argentina

Novartis Investigative Site, Rosario, Argentina

Novartis Investigator Site, Box Hill, Australia

Novartis Investigator Site, Clayton, Australia

Novartis Investigator Site, Garran, Australia

Novartis Investigator Site, Glebe, Australia

Novartis Investigator Site, Kogarah, Australia

Novartis Investigator Site, Nedlands, Australia

Novartis Investigative Site, Barranquilla, Colombia

Novartis Investigative Site, Bogota, Colombia

Novartis Investigator Site, Bogota, Colombia

Novartis Investigative Site, Medellin, Colombia

Novartis Investigator Site, Copenhagen, Denmark

Novartis Investigator Site, Fredericia, Denmark

Novartis Investigator Site, Silkeborg, Denmark

Novartis Investigator Site, Soeborg, Denmark

Novartis Investigator Site, Vejle, Denmark

Novartis Investigator Site, Berlin, Germany

Novartis Investigator Site, Cottbus, Germany

Novartis Investigator Site, Donaustauf, Germany

Novartis Investigator Site, Dortmund, Germany

Novartis Investigator Site, Erfurt, Germany

Novartis Investigator Site, Frankfurt, Germany

Novartis Investigator Site, Gelnhausen, Germany

Novartis Investigator Site, Grosshansdorf, Germany

Novartis Investigator Site, Hannover, Germany

Novartis Investigator Site, Heidelberg, Germany

Novartis Investigator Site, Leipzig, Germany

Novartis Investigator Site, Mainz, Germany

Novartis Investigator Site, Neu-Ulm, Germany

Novartis Investigator Site, Neuss, Germany

Novartis Investigator Site, Potsdam, Germany

Novartis Investigator Site, Rostock, Germany

Novartis Investigator Site, Schwabach, Germany

Novartis Investigator Site, Schwetzingen, Germany

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Additional Information

Starting date: March 2009
Last updated: July 22, 2011

Page last updated: August 23, 2015

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