Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00393458
First received: October 25, 2006
Last updated: July 22, 2011
Last verified: July 2011

October 25, 2006
July 22, 2011
October 2006
July 2008   (final data collection date for primary outcome measure)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 [ Time Frame: Week 12 + 1 day, Day 85 ] [ Designated as safety issue: No ]
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 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
24 h post-dose lung function measured by a special test called “forced expiratory volume in one second” (FEV1) after 12 weeks of treatment
Complete list of historical versions of study NCT00393458 on ClinicalTrials.gov Archive Site
Percentage of Days of Poor Control During 52 Weeks of Treatment [ Time Frame: Baseline to end of study (Week 52) ] [ Designated as safety issue: No ]
Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
  • Percentage of “days of poor control” reported by the patient over the 52 week randomized treatment period
  • Total score of the St. George's Respiratory Questionnaire after 12 weeks of treatment
  • Time to first COPD exacerbation during the 52 week randomized treatment period
Not Provided
Not Provided
 
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or 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
    Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
  • Drug: Formoterol
    Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
  • Drug: Placebo to indacaterol
    Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
  • Drug: Placebo to formoterol
    Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
  • Experimental: Indacaterol 300 μg plus placebo to formoterol
    Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
    Interventions:
    • Drug: Indacaterol
    • Drug: Placebo to formoterol
  • Experimental: Indacaterol 600 μg plus placebo to formoterol
    Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
    Interventions:
    • Drug: Indacaterol
    • Drug: Placebo to formoterol
  • Active Comparator: Formoterol 12 μg plus placebo to indacaterol
    Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
    Interventions:
    • Drug: Formoterol
    • Drug: Placebo to indacaterol
  • Placebo Comparator: Placebo to indacaterol plus placebo to formoterol
    Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
    Interventions:
    • Drug: Placebo to indacaterol
    • Drug: Placebo to formoterol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1732
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:

    1. Smoking history of at least 20 pack years
    2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
    3. Post-bronchodilator FEV1/FVC (forced volume capacity) < 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

      Exclusion Criteria:

  • Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
  • Patients who 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.

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Egypt,   Turkey,   Ecuador,   Spain,   Slovakia,   Argentina,   Chile,   Romania,   Peru,   Colombia,   Netherlands,   Lithuania,   Latvia,   Korea, Republic of,   Italy,   Czech Republic,   Israel,   Hungary,   Germany,   Denmark,   Estonia,   Russian Federation,   France,   United Kingdom,   Switzerland
 
NCT00393458
CQAB149B2334
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis Investigator Site Novartis
Novartis
July 2011

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