Open-label, multi-centre study to compare the effectiveness of QvarTM Autohaler therapy with conventional therapy (similar doses) in children with stable asthma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001928-20-BE

Enrollment

300

Registered

2005-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children aged 7 - 12 with stable mild persistent to moderate persistent asthma (according to the GINA classification) Classification code 10003553

Interventions

Trade Name: Qvar 100µg Autohaler Product Name: Qvar 100µg Autohaler Pharmaceutical Form: Inhalation vapour, solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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 Assess direct and indirect costs associated to asthma during intake of QvarTM AH ;Primary end point(s): •compare the effectiveness of QvarTM AH therapy with conventional fixed combination asthma therapy (similar doses) •assess the safety of QvarTM AH •assess direct and indirect costs associated to asthma during intake of QvarTM AH	—

Measure

Time frame

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 Assess direct and indirect costs associated to asthma during intake of QvarTM AH ;Primary end point(s): •compare the effectiveness of QvarTM AH therapy with conventional fixed combination asthma therapy (similar doses) •assess the safety of QvarTM AH •assess direct and indirect costs associated to asthma during intake of QvarTM AH

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026