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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Asthma
Bronchial Hyperresponsiveness
Interventions Drug: Beclomethasone dipropionate HFA
Drug: placebo
Enrollment 21
Recruitment Details Participants recruited from Pediatric pulmonology out clinic, Rambam Medical Center, Haifa, Israel between March 2009 and January 2010
Pre-assignment Details 40 participants approached, 23 agreed and have been screened, 2 excluded (1 adenosine challenge test negative, 1 obstructive respiratory impairment)
Arm/Group Title Placebo First, Adenosine Challenge Test Qvar First, Adenosine Challenge Test
Hide Arm/Group Description 11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test 10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
Period Title: First Intervention
Started 11 10
Completed 11 10
Not Completed 0 0
Period Title: Washout Period of 2 Weeks
Started 11 10
Completed 11 10
Not Completed 0 0
Period Title: Second Intervention
Started 11 10
Completed 11 10
Not Completed 0 0
Arm/Group Title Placebo First, Adenosine Challenge Test Qvar First, Adenosine Challenge Test Total
Hide Arm/Group Description 11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test 10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
<=18 years
11
 100.0%
10
 100.0%
21
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
4.94  (1.08) 5.05  (1.05) 4.95  (1.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
3
  27.3%
5
  50.0%
8
  38.1%
Male
8
  72.7%
5
  50.0%
13
  61.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title Adenosine Challenge Test
Hide Description 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
Time Frame ten weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Adenosine Challenge Test Qvar First, Adenosine Challenge Test
Hide Arm/Group Description:
11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: mg/ml
18.46  (26.17) 142.61  (71.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo First, Adenosine Challenge Test Qvar First, Adenosine Challenge Test
Hide Arm/Group Description 11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test 10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
All-Cause Mortality
Placebo First, Adenosine Challenge Test Qvar First, Adenosine Challenge Test
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo First, Adenosine Challenge Test Qvar First, Adenosine Challenge Test
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo First, Adenosine Challenge Test Qvar First, Adenosine Challenge Test
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Lea Bentur
Organization: Rambam medical Center
Phone: xx 972 4 854 3263 ext 0502062400
EMail: l_bentur@rambam.health.gov.il
Layout table for additonal information
Responsible Party: l_bentur, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01006655     History of Changes
Other Study ID Numbers: qvar-adenosineCTIL
First Submitted: November 2, 2009
First Posted: November 3, 2009
Results First Submitted: July 10, 2010
Results First Posted: August 31, 2010
Last Update Posted: November 24, 2015