Efficacy and Safety of Different Doses of Indacaterol

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01079130

Run by

Novartis Pharmaceuticals

People needed

511

Starts

2010-02-01

Last updated by the study team

2011-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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 Investigator Site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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