Asthma Clinical Trial
Official title:
The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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