Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

Completed · Phase 2 · Has a placebo group

Conditions studied: Persistent Asthma

In brief

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Key facts

Study ID

NCT01156844

Run by

Novartis Pharmaceuticals

People needed

191

Starts

2010-03-01

Last updated by the study team

2011-08-17

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
• FEV1 ≥50% and ≤90% of predicted normal at screening
• An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

You may not qualify if…

• Smoking history of ≥ 10 years
• Patients with a diagnosis of COPD
• Patients who have been previously intubated for a severe asthma exacerbation/ attack
• Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
• Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 6 weeks prior to screening
• Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
• Patients with Type I or uncontrolled Type II diabetes mellitus
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Anniston, Alabama, United States
• Novartis Investigative Site — Cypress, California, United States
• Novartis Investigative Site — Fresno, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Normal, Illinois, United States
• Novartis Investigative Site — Lafayette, Louisiana, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — Berlin, New Jersey, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigator Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Plano, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Tacoma, Washington, United States
• Novartis Investigative Site — Tacoma, Washington, United States
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Rennes, France
• Novartis Investigative Site — Wiesbaden, Germany
• Novartis Investigative Site — Amman, Jordan

Full record on ClinicalTrials.gov

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