Status:
COMPLETED
Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma
Lead Sponsor:
Novartis
Conditions:
Asthma
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day of treatmen...
Eligibility Criteria
Inclusion
- Males and females 12 - 75 years of age with a diagnosis of persistent asthma
- Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent
- FEV1 at Visit 1 at least 50% of the predicted normal value
- FEV1 reversibility at least 15%
Exclusion
- Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years
- Chronic Obstructive Pulmonary Disease (COPD)
- Seasonal allergy where asthma is likely to deteriorate during the period of the study
- Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months
- A respiratory tract infection within the previous 6 weeks Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00403637
Start Date
November 1 2006
End Date
February 1 2007
Last Update
November 18 2016
Active Locations (5)
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1
Colorado Allergy and Asthma Centres, P.C.
Denver, Colorado, United States, 80230
2
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States, 02747
3
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
4
The Clinical Research Center
St Louis, Missouri, United States, 63141