Trial Outcomes & Findings for Allergens in Inner-City Schools and Childhood Asthma (NCT NCT01756391)

NCT ID: NCT01756391

Last Updated: 2014-12-08

Results Overview

Largest value among the following: Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma

Recruitment status

COMPLETED

Target enrollment

351 participants

Primary outcome timeframe

14 days

Results posted on

2014-12-08

Participant Flow

Participant milestones

Participant milestones
Measure
Observational Cohort
students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
Overall Study
STARTED
351
Overall Study
COMPLETED
319
Overall Study
NOT COMPLETED
32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Allergens in Inner-City Schools and Childhood Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Observational Cohort
n=351 Participants
students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
Age, Continuous
7.9 years
n=5 Participants
Sex: Female, Male
Female
169 Participants
n=5 Participants
Sex: Female, Male
Male
182 Participants
n=5 Participants
Region of Enrollment
United States
351 participants
n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Those with appropriate follow up and school/home allergen exposure data and allergy sensitization data

Largest value among the following: Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma

Outcome measures

Outcome measures
Measure
Observational Cohort
n=284 Participants
students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
Maximum Symptom Days/14 Days
2.7 days
Standard Deviation 4

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

Adverse Events

Observational Cohort

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

Wanda Phipatanakul

Boston Children's Hospital

Phone: 617-355-6117

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place