Efficacy and Safety of Different Doses of Indacaterol

NCT01079130 | Completed Phase 3 Results

• 1 other identifier: CQAB149B2357
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 71

Brief Summary

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

Conditions

Asthma

Keywords

Indacaterol; asthma; salmeterol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment

  Day 2 (after 1 day of treatment)

Study Arms (6)

Indacaterol 18.75 µg

EXPERIMENTAL

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; Drug: Placebo to Salmeterol

Indacaterol 37.5 µg

EXPERIMENTAL

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; Drug: Placebo to Salmeterol

Indacaterol 75 µg

EXPERIMENTAL

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; Drug: Placebo to Salmeterol

Indacaterol 150 µg

EXPERIMENTAL

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; Drug: Placebo to Salmeterol

Salmeterol

ACTIVE COMPARATOR

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; Drug: Placebo to Indacaterol

Placebo

PLACEBO COMPARATOR

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 Indacaterol; Drug: Placebo to Salmeterol

Interventions

Indacaterol DRUG

Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.

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

Salmeterol DRUG

50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.

Salmeterol

Placebo to Indacaterol DRUG

Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.

Placebo; Salmeterol

Placebo to Salmeterol DRUG

Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (71)

Novartis Investigator Site

Glendale, Arizona, 85306, United States

Location

Novartis Investigator Site

Scottsdale, Arizona, 85251, United States

Location

Novartis Investigator Site

Encinitas, California, 92024, United States

Location

Novartis Investigator Site

Huntington Beach, California, 92647, United States

Location

Novartis Investigator Site

Los Angeles, California, 90025, United States

Location

Novartis Investigator Site

Los Angeles, California, 90048, United States

Location

Novartis Investigative Site

Mission Viejo, California, 92691, United States

Location

Novartis Investigator Site

Orange, California, 92868, United States

Location

Novartis Investigator Site

Rancho Mirage, California, 92270, United States

Location

Novartis Investigator Site

Rolling Hills Estates, California, 90274, United States

Location

Novartis Investigator Site

San Diego, California, 92120, United States

Location

Novartis Investigator Site

San Diego, California, 92123, United States

Location

Novartis Investigator Site

San Jose, California, 95117, United States

Location

Novartis Investigator Site

Stockton, California, 95207, United States

Location

Novartis Investigator Site

Colorado Springs, Colorado, 80907, United States

Location

Novartis Investigator Site

Denver, Colorado, 80230, United States

Location

Novartis Investigator Site

Engelwood, Colorado, 80112, United States

Location

Novartis Investigator Site

Lakewood, Colorado, 80401, United States

Location

Novartis Investigative Site

Stamford, Connecticut, 06902, United States

Location

Novartis Investigative Site

Waterbury, Connecticut, 06708, United States

Location

Novartis Investigative site

Destin, Florida, 32541, United States

Location

Novartis Investigative Site

Pensacola, Florida, 32503, United States

Location

Novartis Investigative Site

Pensacola, Florida, 32514, United States

Location

Novartis Investigative Site

Port Orange, Florida, 32127, United States

Location

Novartis Investigative Site

Sarasota, Florida, 34233, United States

Location

Novartis Investigative Site

Tamarac, Florida, 33321, United States

Location

Novartis Investigative Site

Winter Park, Florida, 32789, United States

Location

Novartis Investigator Site

Boise, Idaho, 83704, United States

Location

Novartis Investigator Site

Normal, Illinois, 61761, United States

Location

Novartis Investigative Site

Springfield, Illinois, 62703, United States

Location

Novartis Investigator Site

Overland Park, Kansas, 66210, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40215, United States

Location

Novartis Investigator Site

Lafayette, Louisiana, 70503, United States

Location

Novartis Investigative Site

Baltimore, Maryland, 21236, United States

Location

Novartis Investigator Site

Columbia, Maryland, 21044, United States

Location

Novartis Investigative Site

Wheaton, Maryland, 20902, United States

Location

Novartis Investigative Site

North Dartmouth, Massachusetts, 02747, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, 55402, United States

Location

Novartis Investigator Site

Columbia, Missouri, 65203, United States

Location

Novartis Investigator Site

Rolla, Missouri, 65401, United States

Location

Novartis Investigator Site

St Louis, Missouri, 63141, United States

Location

Novartis Investigator Site

Warrensburg, Missouri, 64093, United States

Location

Novartis Investigative Site

Missoula, Montana, 59808, United States

Location

Novartis Investigator Site

Bellevue, Nebraska, 68123, United States

Location

Novartis Investigator Site

Boys Town, Nebraska, 68010, United States

Location

Novartis Investigative Site

Ocean City, New Jersey, 07712, United States

Location

Novartis Investigative Site

Skillman, New Jersey, 08558, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigator Site

Cadiz, Ohio, 43907, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43215, United States

Location

Novartis Investigative Site

Maumee, Ohio, 43537, United States

Location

Novartis Investigator Site

Oklahoma City, Oklahoma, 73103, United States

Location

Novartis Investigator Site

Lake Oswego, Oregon, 97035, United States

Location

Novartis Investigative Site

Medford, Oregon, 97504, United States

Location

Novartis Investigator Site

Portland, Oregon, 97213, United States

Location

Novartis Investigative Site

Erie, Pennsylvania, 16506, United States

Location

Novartis Investigative Site

Phoenixville, Pennsylvania, 19460, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15243, United States

Location

Novartis Investigative Site

Upland, Pennsylvania, 19013, United States

Location

Novartis Investigative Site

Lincoln, Rhode Island, 02865, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29414, United States

Location

Novartis Investigative site

North Charleston, South Carolina, 29406, United States

Location

Novartis Investigator Site

Austin, Texas, 78758, United States

Location

Novartis Investigator Site

Dallas, Texas, 75231, United States

Location

Novartis Investigator Site

El Paso, Texas, 79903, United States

Location

Novartis Investigator Site

El Paso, Texas, 79925, United States

Location

Novartis Investigator Site

Georgetown, Texas, 78628, United States

Location

Novartis Investigator Site

North Richland Hills, Texas, 76180, United States

Location

Novartis Investigator Site

Waco, Texas, 73712, United States

Location

Novartis Investigator Site

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

indacaterol; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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 1, 2010
• First Posted: March 2, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Last Updated: August 19, 2011
• Results First Posted: August 19, 2011

Record last verified: 2011-07

Locations

US (71)