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A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

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

Intervention: Indacaterol 150 μg (Drug); Tiotropium 18 μg (Drug); Placebo to indacaterol (Drug); Placebo to tiotropium (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 compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

Clinical Details

Official title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 g Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 g od) Delivered Via a HandiHaler, in Patients With Moderate-to-severe COPD

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

Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)

Secondary outcome:

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

Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment

Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment

Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)

Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)

Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)

Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment

Eligibility

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

Criteria:

Inclusion Criteria:

- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic

Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

- a) Smoking history of at least 10 pack-years

- b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of

the predicted normal value

- c) Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria:

- Patients who have received systemic corticosteroids or antibiotics and/or was

hospitalized for a COPD exacerbation in the 6 weeks prior to screening

- 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 applied to the study.

Locations and Contacts

Novartis Investigator Site, Feldbach, Austria

Novartis Investigator Site, Gänserndorf, Austria

Novartis Investigator Site, Hallein, Austria

Novartis Investigator Site, Bruxelles, Belgium

Novartis Investigator Site, Gilly, Belgium

Novartis Investigator Site, Jambes, Belgium

Novartis Investigator Site, Jette, Belgium

Novartis Investigator Site, Liège, Belgium

Novartis Investigator Site, Montigny-le-tilleul, Belgium

Novartis Investigator Site, Oostende, Belgium

Novartis Investigator Site, Saint Vith, Belgium

Novartis Investigator Site, Yvoir, Belgium

Novartis Investigator Site, Calgary, Canada

Novartis Investigative Site, Mississauga, Canada

Novartis Investigative Site, Moncton, Canada

Novartis Investigative Site, New Market, Canada

Novartis Investigative SIte, Quebec, Canada

Novartis Investigative Site, St-Romuald, Canada

Novartis Investigative Site, Sudbury, Canada

Novartis Investigator Site, Barranquilla, Colombia

Novartis Investigator Site, Bogota, Colombia

Novartis Investigator Site, Medellin, Colombia

Novartis Investigator Site, Aalborg, Denmark

Novartis Investigator Site, Frederiksberg, Denmark

Novartis Investigator Site, Næstved, Denmark

Novartis Investigator Site, Roskilde, Denmark

Novartis Investigator Site, Sønderborg, Denmark

Novartis Investigator Site, Vaerlose, Denmark

Novartis Investigator Site, Viborg, Denmark

Novartis Investigator Site, Helsinki, Finland

Novartis Investigator Site, Jyväskylä, Finland

Novartis Investigator Site, Lahti, Finland

Novartis Investigator Site, OYS, Finland

Novartis Investigator Site, Pori, Finland

Novartis Investigator Site, Turku, Finland

Novartis Investigative Site, Ambroise, France

Novartis Investigative Site, Antibes, France

Novartis Investigator Site, Beuvry, France

Novartis Investigator Site, Ferolles-Attily, France

Novartis Investigative Site, Montpellier, France

Novartis Investigator Site, Nantes, France

Novartis Investigative Site, Nice, France

Novartis Investigative Site, Nimes, France

Novartis Investigative Site, Paris, France

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Novartis Investigator Site, Pierre Benite, France

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Additional Information

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

Page last updated: August 23, 2015

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