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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asthma, Bronchial Hyperresponsiveness

Intervention / Treatment
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* Drug: Beclomethasone dipropionate HFA
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo, adenosine challenge test<br>Controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceded and succeeded by AMP challenge test, | Drug: placebo<br>* inhalation twice a day for one month, preceded and followed by adenosine challenge test<br>|
| Active Comparator: Qvar, adenosine challenge test<br>Patients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day | Drug: Beclomethasone dipropionate HFA<br>* 100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test<br>* Other names: Qvar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenosine Challenge Test | 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 | ten weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, preschool children, bronchial hyperresponsiveness, beclometasone dipropionate - HFA, Qvar, Adenosine Challenge test