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Completed

NCT Number: NCT01072448

12-week Efficacy of Indacaterol

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigator Site, Peoria, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, 2008) and:
  • Smoking history of at least 10 pack-years
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
  • Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion criteria

  • Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization 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 co-morbid conditions Other protocol-defined inclusion/exclusion criteria applied to the study.

Treatment and study plan

Indacaterol 75 μg

Drug

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to Indacaterol

Drug

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Primary outcomes

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

    Time frame: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Secondary outcomes

  1. Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)

    Time frame: End of the study (Week 12, Day 84)

    An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 22, 2010
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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