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Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01089127
First received: March 17, 2010
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Indacaterol
Drug: Salmeterol 50 μg
Drug: Placebo to indacaterol
Drug: Placebo to salmeterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease, Using Salmeterol as an Active Control

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15) [ Time Frame: 24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15) ] [ 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 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.


Secondary Outcome Measures:
  • Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2 [ Time Frame: 24 hours post-dose on Day 2 ] [ 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 on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.


Enrollment: 552
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol 18.75 μg
Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Drug: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Experimental: Indacaterol 37.5 μg
Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Drug: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Experimental: Indacaterol 75 μg
Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Drug: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Experimental: Indacaterol 150 μg
Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Drug: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Active Comparator: Salmeterol 50 μg
Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Drug: Salmeterol 50 μg
Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Drug: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo Comparator: Placebo
Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Drug: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Drug: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Smoking history of at least 10 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 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 comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089127

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Locations
United States, Alabama
Novartis Investigator Site
Florence, Alabama, United States, 35630
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Jasper, Alabama, United States, 35501
United States, Arizona
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Phoenix, Arizona, United States, 85006
United States, Arkansas
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Searcy, Arkansas, United States, 72143
United States, California
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Fullerton, California, United States, 92835
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Rancho Mirage, California, United States, 92270
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Riverside, California, United States, 92506
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San Diego, California, United States, 92120
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Stockton, California, United States, 95207
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Temecula, California, United States, 92591
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Walnut Creek, California, United States, 94598
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Wheat Ridge, Colorado, United States, 80033
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Glastonbury, Connecticut, United States, 06033
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Stamford, Connecticut, United States, 06902
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Clearwater, Florida, United States, 33765
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Defuniak Springs, Florida, United States, 32435
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Hollywood, Florida, United States, 33021
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Miami, Florida, United States, 33145
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Pensacola, Florida, United States, 32504
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Pensacola, Florida, United States, 32503
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Tamarac, Florida, United States, 33321
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Madisonville, Kentucky, United States, 42431
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Opelousas, Louisiana, United States, 70570
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Henderson, Nevada, United States, 89014
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Las Vegas, Nevada, United States, 89119
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Lebanon, New Hampshire, United States, 03756
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Cherry Hill, New Jersey, United States, 08003
United States, New York
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Bayside, New York, United States, 11361
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Great Neck, New York, United States, 11023
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Lake Success, New York, United States, 11042
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Larchmont, New York, United States, 10538
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Charlotte, North Carolina, United States, 28207
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Shelby, North Carolina, United States, 28152
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Cadiz, Ohio, United States, 43907
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Canton, Ohio, United States, 44718
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Columbus, Ohio, United States, 43215
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Toledo, Ohio, United States, 43608
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Eugene, Oregon, United States, 97404
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Phoenixville, Pennsylvania, United States, 19460
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Pittsburgh, Pennsylvania, United States, 15243
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Charleston, South Carolina, United States, 29407
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Charleston, South Carolina, United States, 29406-7108
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Easley, South Carolina, United States, 29640
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Greenville, South Carolina, United States, 29615
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Spartanburg, South Carolina, United States, 29303
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Union, South Carolina, United States, 29379
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Cookeville, Tennessee, United States, 38501
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Dickinson, Texas, United States, 77539
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Ft. Worth, Texas, United States, 76104
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McKinney, Texas, United States, 75069
United States, Utah
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Salt Lake City, Utah, United States, 84107
United States, Virginia
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Fredericksburg, Virginia, United States, 22401
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Newport News, Virginia, United States, 23606
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Richmond, Virginia, United States, 23229
United States, Washington
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Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01089127     History of Changes
Other Study ID Numbers: CQAB149B2356
Study First Received: March 17, 2010
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Indacaterol
COPD
salmeterol

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Albuterol
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 25, 2014