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Completed

NCT Number: NCT01006655

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.

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Key information

Conditions

Asthma Bronchial Diseases Bronchial Hyperreactivity Bronchial Hyperresponsiveness Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rambam Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beclomethasone Dipropionate HFA

Drug

100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test

Other names: Qvar

Placebo

Drug

inhalation twice a day for one month, preceded and followed by adenosine challenge test

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 3, 2009
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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