Trial Outcomes & Findings for The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children (NCT NCT01006655)

Last Updated: 2015-11-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

ten weeks

Results posted on

2015-11-24

Participant Flow

Participants recruited from Pediatric pulmonology out clinic, Rambam Medical Center, Haifa, Israel between March 2009 and January 2010

40 participants approached, 23 agreed and have been screened, 2 excluded (1 adenosine challenge test negative, 1 obstructive respiratory impairment)

Participant milestones

Participant milestones
Measure	Placebo First, Adenosine Challenge Test 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	Qvar First, Adenosine 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
First Intervention STARTED	11	10
First Intervention COMPLETED	11	10
First Intervention NOT COMPLETED	0	0
Washout Period of 2 Weeks STARTED	11	10
Washout Period of 2 Weeks COMPLETED	11	10
Washout Period of 2 Weeks NOT COMPLETED	0	0
Second Intervention STARTED	11	10
Second Intervention COMPLETED	11	10
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo First, Adenosine Challenge Test n=11 Participants 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	Qvar First, Adenosine Challenge Test n=10 Participants 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 n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	4.94 years STANDARD_DEVIATION 1.08 • n=5 Participants	5.05 years STANDARD_DEVIATION 1.05 • n=7 Participants	4.95 years STANDARD_DEVIATION 1.05 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Israel	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Placebo First, Adenosine Challenge Test n=11 Participants 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	Qvar First, Adenosine Challenge Test n=11 Participants 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
Adenosine Challenge Test	18.46 mg/ml Standard Deviation 26.17	142.61 mg/ml Standard Deviation 71.6

Adverse Events

Placebo First, Adenosine Challenge Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Qvar First, Adenosine Challenge Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Lea Bentur

Rambam medical Center

Phone: xx 972 4 854 3263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place