Comparative study of the bioactivity of the HFA Fluticasone Dipropionate via current delivery devices - Systemic bioactivity of fluticasone via current delivery devices. Ver 1
- Conditions
- Bronchial Asthma
- Registration Number
- EUCTR2005-004475-37-GB
- Lead Sponsor
- niversity of Dundee ( Research & Innovation Services)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.Mild to moderate stable asthmatics on =800µg BDP or equivalent
2.Male or female 18-65
3.Informed Consent
4.Ability to comply with the requirements of the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Severe asthmatics as defined by an FEV1= 60% or PEF variability > 30% or
with continual daytime or nocturnal symptoms.
2.The use of oral corticosteroids within the last 3 months.
3.Recent respiratory tract infection (2 months).
4.Significant concomitant respiratory disease such as COPD, CF, ABPA,
bronchiectasis and active pulmonary tuberculosis.
5.Any other clinically significant medical condition such as unstable angina,
acute myocardial infarction in the preceding 3 months, recent TIA/
CVA, that may endanger the health or safety of the participant, or
jeopardise the protocol.
6.Any significant abnormal laboratory result as deemed by the investigators
7.Pregnancy, planned pregnancy or lactation
8.Known or suspected contra-indication to any of the IMP’s
9.Concomitant use of medicines (prescribed, over the counter or herbal) that
may interfere with the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method