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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006655
Recruitment Status : Completed
First Posted : November 3, 2009
Results First Posted : August 31, 2010
Last Update Posted : November 24, 2015
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
l_bentur, 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.

Condition or disease Intervention/treatment Phase
Asthma Bronchial Hyperresponsiveness Drug: Beclomethasone dipropionate HFA Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children
Study Start Date : March 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Placebo Comparator: placebo, adenosine challenge test
Controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceded and succeeded by AMP challenge test,
Drug: placebo
inhalation twice a day for one month, preceded and followed by adenosine challenge test

Active Comparator: Qvar, adenosine challenge test
Patients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day
Drug: Beclomethasone dipropionate HFA
100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test
Other Name: Qvar

Primary Outcome Measures :
  1. Adenosine Challenge Test [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006655

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Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Teva Pharmaceutical Industries
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Principal Investigator: Lea Bentur, MD Rambam Health Care Campus
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Responsible Party: l_bentur, Head of pediatric pulmonary institute, Ruth children hospital, Rambam Health Care Campus Identifier: NCT01006655    
Other Study ID Numbers: qvar-adenosineCTIL
First Posted: November 3, 2009    Key Record Dates
Results First Posted: August 31, 2010
Last Update Posted: November 24, 2015
Last Verified: October 2015
Keywords provided by l_bentur, Rambam Health Care Campus:
preschool children
bronchial hyperresponsiveness
beclometasone dipropionate - HFA
Adenosine Challenge test
Additional relevant MeSH terms:
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Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents