Trial Outcomes & Findings for Bronchodilator Response in 4-12 Years Chinese Controller Naive Asthmatic Children (NCT NCT01500525)

Results Overview

1. To observe bronchodilator response(BDR) distribution curve for Chinese non-asthmatic children from 4-12 years, BDR calculated as: (FEV 1 L post-bronchodilator - FEV 1 L pre-bronchodilator)/FEV 1 L pre-bronchodilator × 100%. 2. To observe BDR distribution curve for Chinese controller-naïve asthmatic children from 4-12 years 3. To compare BDR values between non-asthmatic group and controller-naïve asthmatic group, and analyze appropriate cut-off point value

Recruitment status

COMPLETED

Target enrollment

587 participants

Primary outcome timeframe

3 years

Results posted on

2021-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Asthmatic Children children diagnosed by a specialist as asthmatic patients	Non-asthmatic Children children who are healthy and who do not have respiratory syndrom
Overall Study STARTED	286	301
Overall Study COMPLETED	286	301
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bronchodilator Response in 4-12 Years Chinese Controller Naive Asthmatic Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asthmatic Children n=286 Participants children diagnosed by a specialist as asthmatic patients	Non-asthmatic Children n=301 Participants children who are healthy and who do not have respiratory syndrom	Total n=587 Participants Total of all reporting groups
Age, Continuous	7.22 years STANDARD_DEVIATION 2.44 • n=99 Participants	7.56 years STANDARD_DEVIATION 2.41 • n=107 Participants	7.41 years STANDARD_DEVIATION 2.43 • n=206 Participants
Sex: Female, Male Female	92 Participants n=99 Participants	141 Participants n=107 Participants	233 Participants n=206 Participants
Sex: Female, Male Male	194 Participants n=99 Participants	160 Participants n=107 Participants	354 Participants n=206 Participants

PRIMARY outcome

Timeframe: 3 years

Population: asthmatic group : children diagnosed by a specialist as asthmatic patients; Non-asthmatic Children: children who are healthy and who do not have respiratory syndrom

1. To observe bronchodilator response(BDR) distribution curve for Chinese non-asthmatic children from 4-12 years, BDR calculated as: (FEV 1 L post-bronchodilator - FEV 1 L pre-bronchodilator)/FEV 1 L pre-bronchodilator × 100%. 2. To observe BDR distribution curve for Chinese controller-naïve asthmatic children from 4-12 years 3. To compare BDR values between non-asthmatic group and controller-naïve asthmatic group, and analyze appropriate cut-off point value

Outcome measures

Outcome measures
Measure	Asthmatic Children n=286 Participants children diagnosed by a specialist as asthmatic patients	Non-asthmatic Children n=301 Participants children who are healthy and who do not have respiratory syndrom
Bronchodilator Response in Asthmatic Children	9.45 percentage of BDR Standard Deviation 9.15	3.30 percentage of BDR Standard Deviation 3.85

Adverse Events

Asthmatic Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-asthmatic Children

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

Ling Cao，MD,Pulmonologist, Professor

Capital Institute of Pediatrics

Phone: 86-13910610319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place