Status:
COMPLETED
A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands
Lead Sponsor:
SkyePharma AG
Collaborating Sponsors:
Abbott
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of the two medications in one inhaler....
Detailed Description
This is a Phase-1 randomized, double-blind, placebo- and active-controlled, parallel group 6 week study to evaluate the effect on the HPA axis of treatment with SKP FlutiForm 250/10 mg HFA pMDI twice ...
Eligibility Criteria
Inclusion
- Age 18-65 at the Screening Visit;
- History of asthma for at least 6 months prior to Screening Visit
- Well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to Screening Visit
- Female subjects that are not pregnant or lactating
- Otherwise healthy as determined by the Investigator.
Exclusion
- Life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the Screening Visit;
- Significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis)
- Use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing
- An upper or lower respiratory tract infection within the last 4 weeks pior to Screening Visit or acute illness or infection within 6 weeks prior to dosing
- Any significant disease or major disorder that may jeopardize subject safety
- History of tabacco use within 6 months prior to dosing and/or smoking history \> 10 pack-years
- Female subjects on hormone replacement therapy or using birth control involving hormones in the past 6 months
- Additional inclusion and exclusion criteria will evaluated by the investigator.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00657774
Start Date
April 1 2008
End Date
September 1 2008
Last Update
December 1 2008
Active Locations (19)
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1
Investigational site
Phoenix, Arizona, United States, 85006
2
Investigational site
Anaheim, California, United States, 92801
3
Investigational site
Long Beach, California, United States, 90806
4
Investigational site
San Diego, California, United States, 92120