Status:
COMPLETED
Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Persistent Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT01156844
Start Date
March 1 2010
Last Update
August 17 2011
Active Locations (30)
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1
Novartis Investigative Site
Anniston, Alabama, United States, 36207
2
Novartis Investigative Site
Cypress, California, United States, 90630
3
Novartis Investigative Site
Fresno, California, United States, 93726
4
Novartis Investigative Site
San Diego, California, United States, 92120