Efficacy and Safety of Different Doses of Indacaterol

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

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Indacaterol; Drug: Placebo to Salmeterol; Drug: Salmeterol; Drug: Placebo to Indacaterol

• Study Type: Interventional
• Enrollment (Actual): 511
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Novartis Investigator Site
    • Scottsdale, Arizona, United States, 85251
      • Novartis Investigator Site
  • California
    • Encinitas, California, United States, 92024
      • Novartis Investigator Site
    • Huntington Beach, California, United States, 92647
      • Novartis Investigator Site
    • Los Angeles, California, United States, 90025
      • Novartis Investigator Site
    • Los Angeles, California, United States, 90048
      • Novartis Investigator Site
    • Mission Viejo, California, United States, 92691
      • Novartis Investigative Site
    • Orange, California, United States, 92868
      • Novartis Investigator Site
    • Rancho Mirage, California, United States, 92270
      • Novartis Investigator Site
    • Rolling Hills Estates, California, United States, 90274
      • Novartis Investigator Site
    • San Diego, California, United States, 92120
      • Novartis Investigator Site
    • San Diego, California, United States, 92123
      • Novartis Investigator Site
    • San Jose, California, United States, 95117
      • Novartis Investigator Site
    • Stockton, California, United States, 95207
      • Novartis Investigator Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Novartis Investigator Site
    • Denver, Colorado, United States, 80230
      • Novartis Investigator Site
    • Engelwood, Colorado, United States, 80112
      • Novartis Investigator Site
    • Lakewood, Colorado, United States, 80401
      • Novartis Investigator Site
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Novartis Investigative Site
    • Waterbury, Connecticut, United States, 06708
      • Novartis Investigative Site
  • Florida
    • Destin, Florida, United States, 32541
      • Novartis Investigative Site
    • Pensacola, Florida, United States, 32503
      • Novartis Investigative Site
    • Pensacola, Florida, United States, 32514
      • Novartis Investigative Site
    • Port Orange, Florida, United States, 32127
      • Novartis Investigative Site
    • Sarasota, Florida, United States, 34233
      • Novartis Investigative Site
    • Tamarac, Florida, United States, 33321
      • Novartis Investigative Site
    • Winter Park, Florida, United States, 32789
      • Novartis Investigative Site
  • Idaho
    • Boise, Idaho, United States, 83704
      • Novartis Investigator Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • Novartis Investigator Site
    • Springfield, Illinois, United States, 62703
      • Novartis Investigative Site
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Novartis Investigator Site
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Novartis Investigative Site
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Novartis Investigator Site
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • Novartis Investigative Site
    • Columbia, Maryland, United States, 21044
      • Novartis Investigator Site
    • Wheaton, Maryland, United States, 20902
      • Novartis Investigative Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Novartis Investigative Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Novartis Investigative Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Novartis Investigator Site
    • Rolla, Missouri, United States, 65401
      • Novartis Investigator Site
    • St. Louis, Missouri, United States, 63141
      • Novartis Investigator Site
    • Warrensburg, Missouri, United States, 64093
      • Novartis Investigator Site
  • Montana
    • Missoula, Montana, United States, 59808
      • Novartis Investigative Site
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Novartis Investigator Site
    • Boys Town, Nebraska, United States, 68010
      • Novartis Investigator Site
  • New Jersey
    • Ocean, New Jersey, United States, 07712
      • Novartis Investigative Site
    • Skillman, New Jersey, United States, 08558
      • Novartis Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Novartis Investigative Site
    • Raleigh, North Carolina, United States, 27607
      • Novartis Investigative Site
  • Ohio
    • Cadiz, Ohio, United States, 43907
      • Novartis Investigator Site
    • Columbus, Ohio, United States, 43215
      • Novartis Investigative Site
    • Maumee, Ohio, United States, 43537
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Novartis Investigator Site
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Novartis Investigator Site
    • Medford, Oregon, United States, 97504
      • Novartis Investigative Site
    • Portland, Oregon, United States, 97213
      • Novartis Investigator Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • Novartis Investigative Site
    • Phoenixville, Pennsylvania, United States, 19460
      • Novartis Investigative Site
    • Pittsburgh, Pennsylvania, United States, 15243
      • Novartis Investigative Site
    • Upland, Pennsylvania, United States, 19013
      • Novartis Investigative Site
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Novartis Investigative Site
    • North Charleston, South Carolina, United States, 29406
      • Novartis Investigative Site
  • Texas
    • Austin, Texas, United States, 78758
      • Novartis Investigator Site
    • Dallas, Texas, United States, 75231
      • Novartis Investigator Site
    • El Paso, Texas, United States, 79903
      • Novartis Investigator Site
    • El Paso, Texas, United States, 79925
      • Novartis Investigator Site
    • Georgetown, Texas, United States, 78628
      • Novartis Investigator Site
    • North Richland Hills, Texas, United States, 76180
      • Novartis Investigator Site
    • Waco, Texas, United States, 73712
      • Novartis Investigator Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Novartis Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Indacaterol; Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.; 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).
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.	Drug: Indacaterol; Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.; 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).
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.	Drug: Indacaterol; Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.; 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).
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.	Drug: Indacaterol; Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.; 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).
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.	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.
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.	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).; Drug: Placebo to Indacaterol; Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) 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.	Day 15 (after 2 weeks of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) 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.	Day 2 (after 1 day of treatment)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 19, 2011
• Last Update Submitted That Met QC Criteria: July 22, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: asthma; salmeterol; Indacaterol
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Salmeterol Xinafoate
• Other Study ID Numbers: CQAB149B2357