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Trial record 83 of 1197 for:    Adenosine

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

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ClinicalTrials.gov Identifier: NCT01006655
Recruitment Status : Completed
First Posted : November 3, 2009
Results First Posted : August 31, 2010
Last Update Posted : November 24, 2015
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
l_bentur, Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE November 2, 2009
First Posted Date  ICMJE November 3, 2009
Results First Submitted Date  ICMJE July 10, 2010
Results First Posted Date  ICMJE August 31, 2010
Last Update Posted Date November 24, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2009)
Adenosine Challenge Test [ Time Frame: ten weeks ]
Change History Complete list of historical versions of study NCT01006655 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children
Official Title  ICMJE The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Bronchial Hyperresponsiveness
Intervention  ICMJE
  • 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
  • Drug: placebo
    inhalation twice a day for one month, preceded and followed by adenosine challenge test
Study Arms  ICMJE
  • 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,
    Intervention: Drug: 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
    Intervention: Drug: Beclomethasone dipropionate HFA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2010)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2009)
26
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01006655
Other Study ID Numbers  ICMJE qvar-adenosineCTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party l_bentur, Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Teva Pharmaceutical Industries
Investigators  ICMJE
Principal Investigator: Lea Bentur, MD Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP