The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children
Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Bronchial Hyperresponsiveness
Intervention: Beclomethasone dipropionate HFA (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s): Lea Bentur, MD, Principal Investigator, Affiliation: Rambam Health Care Campus
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.
Clinical Details
Official title: The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
Eligibility
Minimum age: 3 Years.
Maximum age: 7 Years.
Gender(s): Both.
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
Locations and Contacts
Rambam Medical Center, Haifa, Israel
Additional Information
Related publications: Menzies D, Nair A, Hopkinson P, McFarlane L, Lipworth BJ. Differential anti-inflammatory effects of large and small particle size inhaled corticosteroids in asthma. Allergy. 2007 Jun;62(6):661-7. Koh YY, Lee MH, Sun YH, Park Y, Kim CK. Improvement in bronchial hyperresponsiveness with inhaled corticosteroids in children with asthma: importance of family history of bronchial hyperresponsiveness. Am J Respir Crit Care Med. 2002 Aug 1;166(3):340-5. Hakim F, Vilozni D, Adler A, Livnat G, Tal A, Bentur L. The effect of montelukast on bronchial hyperreactivity in preschool children. Chest. 2007 Jan;131(1):180-6.
Starting date: March 2009
Last updated: August 11, 2010
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