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

NCT01089127 | Completed Phase 3 Results

• 1 other identifier: CQAB149B2356
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 69

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Indacaterol; COPD; salmeterol

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15)

  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.

  24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)

Secondary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2

  24 hours post-dose on Day 2

Study Arms (6)

Indacaterol 18.75 μg

EXPERIMENTAL

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; Drug: Placebo to salmeterol

Indacaterol 37.5 μg

EXPERIMENTAL

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; Drug: Placebo to salmeterol

Indacaterol 75 μg

EXPERIMENTAL

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; Drug: Placebo to salmeterol

Indacaterol 150 μg

EXPERIMENTAL

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; Drug: Placebo to salmeterol

Salmeterol 50 μg

ACTIVE COMPARATOR

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; Drug: Placebo to indacaterol

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo to salmeterol

Interventions

Indacaterol DRUG

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Indacaterol 150 μg; Indacaterol 18.75 μg; Indacaterol 37.5 μg; Indacaterol 75 μg

Salmeterol 50 μg DRUG

Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Salmeterol 50 μg

Placebo to indacaterol DRUG

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo; Salmeterol 50 μg

Placebo to salmeterol DRUG

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Indacaterol 150 μg; Indacaterol 18.75 μg; Indacaterol 37.5 μg; Indacaterol 75 μg; Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Smoking history of at least 10 pack-years
• Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
• Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (69)

Novartis Investigator Site

Florence, Alabama, 35630, United States

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Jasper, Alabama, 35501, United States

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Phoenix, Arizona, 85006, United States

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Searcy, Arkansas, 72143, United States

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Fullerton, California, 92835, United States

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Rancho Mirage, California, 92270, United States

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Riverside, California, 92506, United States

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San Diego, California, 92120, United States

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Stockton, California, 95207, United States

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Temecula, California, 92591, United States

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Walnut Creek, California, 94598, United States

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Wheat Ridge, Colorado, 80033, United States

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Glastonbury, Connecticut, 06033, United States

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Stamford, Connecticut, 06902, United States

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Clearwater, Florida, 33765, United States

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DeFuniak Springs, Florida, 32435, United States

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Hollywood, Florida, 33021, United States

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Miami, Florida, 33145, United States

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Pensacola, Florida, 32503, United States

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Pensacola, Florida, 32504, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33603, United States

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O'Fallon, Illinois, 62269, United States

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Florence, Kentucky, 41017, United States

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Madisonville, Kentucky, 42431, United States

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Opelousas, Louisiana, 70570, United States

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Columbia, Maryland, 21044, United States

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Edina, Minnesota, 55435, United States

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Fridley, Minnesota, 55432, United States

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Minneapolis, Minnesota, 55402, United States

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Ozark, Missouri, 65721, United States

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St Louis, Missouri, 63141, United States

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Bellevue, Nebraska, 68123, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68134, United States

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Henderson, Nevada, 89014, United States

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Las Vegas, Nevada, 89119, United States

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Las Vegas, Nevada, 89183, United States

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Lebanon, New Hampshire, 03756, United States

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Cherry Hill, New Jersey, 08003, United States

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Bayside, New York, 11361, United States

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Great Neck, New York, 11023, United States

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Lake Success, New York, 11042, United States

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Larchmont, New York, 10538, United States

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Charlotte, North Carolina, 28207, United States

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Shelby, North Carolina, 28152, United States

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Cadiz, Ohio, 43907, United States

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Canton, Ohio, 44718, United States

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Columbus, Ohio, 43215, United States

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Toledo, Ohio, 43608, United States

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Eugene, Oregon, 97404, United States

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Medford, Oregon, 97504, United States

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Phoenixville, Pennsylvania, 19460, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Charleston, South Carolina, 29406-7108, United States

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Charleston, South Carolina, 29407, United States

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Easley, South Carolina, 29640, United States

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Greenville, South Carolina, 29615, United States

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Spartanburg, South Carolina, 29303, United States

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Union, South Carolina, 29379, United States

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Cookeville, Tennessee, 38501, United States

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Dickinson, Texas, 77539, United States

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Fort Worth, Texas, 76104, United States

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McKinney, Texas, 75069, United States

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Salt Lake City, Utah, 84107, United States

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Fredericksburg, Virginia, 22401, United States

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Newport News, Virginia, 23606, United States

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Richmond, Virginia, 23229, United States

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Tacoma, Washington, 98405, United States

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 19, 2011
• Results First Posted: August 19, 2011

Record last verified: 2011-07

Locations

US (69)