Open-label, multi-centre study to compare the effectiveness of QvarTM Autohaler therapy with conventional therapy (similar doses) in children with stable asthma
- Conditions
- Children aged 7 - 12 with stable mild persistent to moderate persistent asthma (according to the GINA classification)Classification code 10003553
- Registration Number
- EUCTR2004-001928-20-BE
- Lead Sponsor
- CB Pharma Belgium
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 300
- Written informed consent signed by child and both parents
- Children from 7 (inclusive) to 12 (inclusive) years old
- Diagnosed since at least 6 months with mild persistent to moderate persistent asthma (according the GINA Guidelines)
- Treated since at least 1 month with Seretide (fluticasonpropionate and salmeterol) 400 mcg max discus haler daily or Symbicort (budenoside and formoterolfumarate) 600 mcg max turbohaler daily
- >60% PEFR after withholding bèta-2-agonist therapy for at least 4 hours measured at visit 1
- Willing to comply with daily dairy recording and with visit schedule
- Otherwise healthy
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
- Asthma treatment different from Seretide discus haler daily or Symbicort turbohaler daily
- Oral/ rectal/ intravenous corticoid treatment
- Hypersensitivity to one of the drugs used during study or for inhaled excipient.
- Continuous use of bèta-blockers
- Acute respiratory tract infection during the past 2 weeks
- Oral candidiasis which is clinically visible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Compare the effectiveness of QvarTM AH therapy with conventional (fixed combination) asthma therapy (similar doses) ;Secondary Objective: Assess the safety of QvarTM AH <br>Assess direct and indirect costs associated to asthma during intake of QvarTM AH<br>;Primary end point(s): •compare the effectiveness of QvarTM AH therapy with conventional fixed combination asthma therapy (similar doses) <br><br>•assess the safety of QvarTM AH <br><br>•assess direct and indirect costs associated to asthma during intake of QvarTM AH<br>
- Secondary Outcome Measures
Name Time Method