Status:
COMPLETED
Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma...
Eligibility Criteria
Inclusion
- Main
- Written informed consent
- Good health with the exception of bronchial asthma (for at least 6 months)
- FEV1 \> 60% to \< 80% of predicted (if pretreated with inhaled steroids only)
- FEV1 \> 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller)
- Main
Exclusion
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists
- Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function
- Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years
- Use of other drugs not allowed
- Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00314509
Start Date
July 1 2005
End Date
January 1 2006
Last Update
December 5 2016
Active Locations (26)
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1
Altana Pharma/Nycomed
Grenoble, France, 38100
2
Altana Pharma/Nycomed
Montpellier, France, 34295
3
Altana Pharma/Nycomed
Berlin, Germany, 14050
4
Altana Pharma/Nycomed
Großhansdorf, Germany, 22927