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

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01006655
First received: November 2, 2009
Last updated: August 11, 2010
Last verified: November 2009
  Purpose

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 Intervention Phase
Asthma
Bronchial Hyperresponsiveness
Drug: Beclomethasone dipropionate HFA
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Adenosine Challenge Test [ Time Frame: ten weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 21
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo
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

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

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006655

Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Lea Bentur, MD Rambam Health Care Campus
  More Information

Publications:
Responsible Party: Professor Lea Bentur, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01006655     History of Changes
Other Study ID Numbers: qvar-adenosineCTIL
Study First Received: November 2, 2009
Results First Received: July 10, 2010
Last Updated: August 11, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
asthma
preschool children
bronchial hyperresponsiveness
beclometasone dipropionate - HFA
Qvar
Adenosine Challenge test

Additional relevant MeSH terms:
Asthma
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Adenosine
Beclomethasone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 28, 2014