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Efficacy and Safety of Different Doses of Indacaterol

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ClinicalTrials.gov Identifier: NCT01079130
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : August 19, 2011
Last Update Posted : August 19, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE March 1, 2010
First Posted Date  ICMJE March 2, 2010
Results First Submitted Date  ICMJE July 22, 2011
Results First Posted Date  ICMJE August 19, 2011
Last Update Posted Date August 19, 2011
Study Start Date  ICMJE February 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment [ Time Frame: Day 15 (after 2 weeks of treatment) ]
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
Trough forced expiratory volume in 1 second (FEV1) [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment [ Time Frame: Day 2 (after 1 day of treatment) ]
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
Trough FEV1 [ Time Frame: After 1 day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Different Doses of Indacaterol
Official Title  ICMJE A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control
Brief Summary This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Indacaterol
    Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
  • Drug: Salmeterol
    50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
  • Drug: Placebo to Indacaterol
    Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.
  • Drug: Placebo to Salmeterol
    Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
Study Arms  ICMJE
  • Experimental: Indacaterol 18.75 µg

    Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks.

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

    Interventions:
    • Drug: Indacaterol
    • Drug: Placebo to Salmeterol
  • Experimental: Indacaterol 37.5 µg

    Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.

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

    Interventions:
    • Drug: Indacaterol
    • Drug: Placebo to Salmeterol
  • Experimental: Indacaterol 75 µg

    Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.

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

    Interventions:
    • Drug: Indacaterol
    • Drug: Placebo to Salmeterol
  • Experimental: Indacaterol 150 µg

    Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks.

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

    Interventions:
    • Drug: Indacaterol
    • Drug: Placebo to Salmeterol
  • Active Comparator: Salmeterol

    Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks.

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

    Interventions:
    • Drug: Salmeterol
    • Drug: Placebo to Indacaterol
  • Placebo Comparator: Placebo

    Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.

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

    Interventions:
    • Drug: Placebo to Indacaterol
    • Drug: Placebo to Salmeterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2011)
511
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2010)
558
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a diagnosis of asthma, and:

    1. Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
    2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal
    3. An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol

Exclusion Criteria:

  • Smoking history >10 pack-years
  • Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
  • Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
  • Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
  • Patients who have had an intubation for a severe asthma exacerbation
  • Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 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 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
  • Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01079130
Other Study ID Numbers  ICMJE CQAB149B2357
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2011

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