Asthma
Conditions
Interventions
Trade Name: Beclazone
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Beclomethasone dipropionate
Other descriptive name: Inhaled Corticosteroid
Concentration unit: µg mic
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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: 1. Extra-fine formulations of beclometasone dipropionate 2. Standard formulations of beclometasone dipropionate 3. Extra-fine beclametasone dipropionate plus oral motelukast | — |
Countries
United Kingdom
Outcome results
None listed