The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children

Phase 2

Completed

• Conditions: Asthma; Bronchial Hyperresponsiveness
• Interventions: Drug: placebo; Drug: Beclomethasone dipropionate HFA

• Registration Number: NCT01006655
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Detailed Description

26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge test, will received in a randomized, double blind, cross over assignment Beclometasone dipropionate (100µg twice a day) or placebo, through an inhaler (autohaler) device, attached to a spacer device, during four consecutive weeks. Adenosine Challenge test will be performed another time at the end of this four weeks period. After 2 weeks with no medication (wash out period) the patients will receive the second intervention (beclometasone dipropionate or placebo) in a cross over manner and will be submitted to the last adenosine challenge test.

Clinical evaluation, resting spirometry and subjective evaluation through an analogical symptoms scale will be recorded in each visit.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Results First Submitted: 2010-07-10
• Results First Submitted QC: 2010-08-11
• Results First Posted: 2010-08-31
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo, adenosine challenge test	placebo	Controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceded and succeeded by AMP challenge test,
Qvar, adenosine challenge test	Beclomethasone dipropionate HFA	Patients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day

Primary Outcome Measures

Name	Time	Method
Adenosine Challenge Test	ten weeks	Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel