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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006655
• Other study ID #: qvar-adenosineCTIL
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2009
• Last updated: October 28, 2015
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: October 2015
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity
• Bronchial Hyperresponsiveness

Intervention

Drug:
• Beclomethasone dipropionate HFA
100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test
• placebo
inhalation twice a day for one month, preceded and followed by adenosine challenge test

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Teva Pharmaceutical Industries

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No