A Proof of Concept Study into the Effects on Inhlaed Extra-Fine and Standard Formulations of Beclomethasone Dipropionate and Oral Montelukast on Surrogate Markers of Small and Large Airway Inflammation in Asthma - Small and large airway inflammation in asthma
- Conditions
- Asthma
- Registration Number
- EUCTR2005-001997-29-GB
- Lead Sponsor
- niversity of Dundee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Male or Female age 18-65 years old
Ability to give informed consent
Mild or Moderate persistent asthma
FEV1 > 60%
Starting dose of inhaled steroid less than 1000 microgrames of beclometasone dipropionate or equivalent
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
Recent respiratory tract infection
Significant concomitant respiratory disease
Any other clinically significant medical condition that may endanger the health or safety of the participant
Any significant laboratory result
Use of oral corticosteroids within the last three months
Pregnacy, planned pregnancy or lactation
Current or ex-smokers
Known or suspected contra-indication to any of the IMP's
Concomitantr use of medication (including OTC medication) 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 Main Objective: To determine whether extra-fine preperations of inhaled beclometasone dipropionat e preferentially suppress inflammation in small airways, over standard 'coarse' preperations in asthmatic subjects. To determine whether the oral anti-inflammatory agent Singulair confers additional benefit over and above that afforded by inhaled corticosteroids on small airway infllammation. The degree of inflammation will be quantified using the surrogate inflammatory marker nirtic oxide.<br>;Secondary Objective: To quantify the effects of both extra-fine and standard formulations of inhaled beclometasone dipropionate on surrogate markers of inflammation, and respiratory function;Primary end point(s): Concentration of exhaled Nitic oxide before and after treatment with:<br>1. Extra-fine formulations of beclometasone dipropionate<br>2. Standard formulations of beclometasone dipropionate<br>3. Extra-fine beclametasone dipropionate plus oral motelukast
- Secondary Outcome Measures
Name Time Method