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Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01068600
First received: February 12, 2010
Last updated: July 22, 2011
Last verified: July 2011
History of Changes

February 12, 2010
July 22, 2011
January 2010
June 2010   (final data collection date for primary outcome measure)
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.
24-hour post-dose (trough) forced expiratory volume in 1 second (FEV1) [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01068600 on ClinicalTrials.gov Archive Site
Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.
Transitional dyspnoea index (TDI) total score [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
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

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Indacaterol
    Once daily via single-dose dry powder inhaler (SDDPI)
  • Drug: Placebo to indacaterol
    Once daily via SDDPI
  • Experimental: Indacaterol 75 µg

    Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks.

    Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

    Intervention: Drug: Indacaterol
  • Placebo Comparator: Placebo

    Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks.

    Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

    Intervention: Drug: Placebo to indacaterol
Kerwin EM, Gotfried MH, Lawrence D, Lassen C, Kramer B. Efficacy and tolerability of indacaterol 75 ?g once daily in patients aged ?40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies. Clin Ther. 2011 Dec;33(12):1974-84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
Not Provided
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

    1. Smoking history of at least 10 pack-years
    2. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
    3. 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 for 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 may apply
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01068600
CQAB149B2355
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP