Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
511 participants
INTERVENTIONAL
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Indacaterol
Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
Placebo to Salmeterol
Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
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.
Indacaterol
Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
Placebo to Salmeterol
Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
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.
Indacaterol
Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
Placebo to Salmeterol
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 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.
Indacaterol
Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
Placebo to Salmeterol
Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
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.
Salmeterol
50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Placebo to Indacaterol
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.
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.
Placebo to Indacaterol
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.
Placebo to Salmeterol
Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
Interventions
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Indacaterol
Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
Salmeterol
50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Placebo to Indacaterol
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.
Placebo to Salmeterol
Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigator Site
Lake Oswego, Oregon, United States
Novartis Investigative Site
Medford, Oregon, United States
Novartis Investigator Site
Portland, Oregon, United States
Novartis Investigator Site
Glendale, Arizona, United States
Novartis Investigator Site
Scottsdale, Arizona, United States
Novartis Investigator Site
Encinitas, California, United States
Novartis Investigator Site
Huntington Beach, California, United States
Novartis Investigator Site
Los Angeles, California, United States
Novartis Investigator Site
Los Angeles, California, United States
Novartis Investigative Site
Mission Viejo, California, United States
Novartis Investigator Site
Orange, California, United States
Novartis Investigator Site
Rancho Mirage, California, United States
Novartis Investigator Site
Rolling Hills Estates, California, United States
Novartis Investigator Site
San Diego, California, United States
Novartis Investigator Site
San Diego, California, United States
Novartis Investigator Site
San Jose, California, United States
Novartis Investigator Site
Stockton, California, United States
Novartis Investigator Site
Colorado Springs, Colorado, United States
Novartis Investigator Site
Denver, Colorado, United States
Novartis Investigator Site
Engelwood, Colorado, United States
Novartis Investigator Site
Lakewood, Colorado, United States
Novartis Investigative Site
Stamford, Connecticut, United States
Novartis Investigative Site
Waterbury, Connecticut, United States
Novartis Investigative site
Destin, Florida, United States
Novartis Investigative Site
Pensacola, Florida, United States
Novartis Investigative Site
Pensacola, Florida, United States
Novartis Investigative Site
Port Orange, Florida, United States
Novartis Investigative Site
Sarasota, Florida, United States
Novartis Investigative Site
Tamarac, Florida, United States
Novartis Investigative Site
Winter Park, Florida, United States
Novartis Investigator Site
Boise, Idaho, United States
Novartis Investigator Site
Normal, Illinois, United States
Novartis Investigative Site
Springfield, Illinois, United States
Novartis Investigator Site
Overland Park, Kansas, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigator Site
Lafayette, Louisiana, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigator Site
Columbia, Maryland, United States
Novartis Investigative Site
Wheaton, Maryland, United States
Novartis Investigative Site
North Dartmouth, Massachusetts, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigator Site
Columbia, Missouri, United States
Novartis Investigator Site
Rolla, Missouri, United States
Novartis Investigator Site
St Louis, Missouri, United States
Novartis Investigator Site
Warrensburg, Missouri, United States
Novartis Investigative Site
Missoula, Montana, United States
Novartis Investigator Site
Bellevue, Nebraska, United States
Novartis Investigator Site
Boys Town, Nebraska, United States
Novartis Investigative Site
Ocean City, New Jersey, United States
Novartis Investigative Site
Skillman, New Jersey, United States
Novartis Investigative Site
Charlotte, North Carolina, United States
Novartis Investigative Site
Raleigh, North Carolina, United States
Novartis Investigator Site
Cadiz, Ohio, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Maumee, Ohio, United States
Novartis Investigator Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Erie, Pennsylvania, United States
Novartis Investigative Site
Phoenixville, Pennsylvania, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Upland, Pennsylvania, United States
Novartis Investigative Site
Lincoln, Rhode Island, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative site
North Charleston, South Carolina, United States
Novartis Investigator Site
Austin, Texas, United States
Novartis Investigator Site
Dallas, Texas, United States
Novartis Investigator Site
El Paso, Texas, United States
Novartis Investigator Site
El Paso, Texas, United States
Novartis Investigator Site
Georgetown, Texas, United States
Novartis Investigator Site
North Richland Hills, Texas, United States
Novartis Investigator Site
Waco, Texas, United States
Novartis Investigator Site
Seattle, Washington, United States
Countries
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Other Identifiers
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CQAB149B2357
Identifier Type: -
Identifier Source: org_study_id
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