Phase 2
N=21
The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children
Asthma · Bronchial Hyperresponsiveness
Bottom Line
View on ClinicalTrials.gov: NCT01006655 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Adenosine Challenge Test — 18.46; 142.61 mg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Beclomethasone dipropionate HFA (Drug); placebo (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Rambam Health Care Campus
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adenosine Challenge Test |
18.46; 142.61 | — |
Summary
Respiratory diseases including Asthma are high prevalent among preschool children. Specific treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg, that is supposed to reach the small airways at higher concentrations and be more suitable to patients who don't cooperate properly to the procedure of inhalation.
The investigators' group has reported successfully the possibility to perform Pulmonary Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported relation between asthma control and reduction in airway hyperreactivity. The purpose of this study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways hyperreactivity in preschool children, as demonstrated by adenosine challenge test.
Eligibility Criteria
Inclusion Criteria
- clinical diagnosis of mild asthma
- children aged between 3 - 6 years old
- able to perform spirometry and adenosine challenge test
- positive challenge test at the time of inclusion
- without prophylactic treatment for asthma
- signed informed consent to join the research by the parents or legal tutor
Exclusion Criteria
- other chronic diseases
- use of oral steroids in the last two months
- emergency room visit in the last two months
- pneumonia in the last two months
- impossibility to perform lung function tests
- disagreement of the parents or legal tutor
Data sourced from ClinicalTrials.gov (NCT01006655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.