NCT01913795

Brief Summary

The investigators aim to pilot the role of school based intervention consisting of enhanced integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started May 2013

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 14, 2015

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

2.2 years

First QC Date

May 21, 2013

Results QC Date

July 29, 2015

Last Update Submit

June 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asthma Symptoms

    number of days of wheezing/cough

    over a two week period at Baseline and Months 3, 6, 9 and 12

Secondary Outcomes (1)

  • Lung Function

    measured at baseline and months 6 and 12

Study Arms (4)

Environmental Intervention

ACTIVE COMPARATOR

4 classroom air purifiers and school integrated pest management environmental intervention

Other: integrated pest managementOther: air purifier

Sham and Control

PLACEBO COMPARATOR

4 sham air purifiers and no school integrated pest management environmental intervention

Other: Sham air purifier

Active Air Purifier and Control

PLACEBO COMPARATOR

4 air purifiers and no school integrated pest management environmental intervention

Other: air purifier

Sham and Integrated Pest Management

SHAM COMPARATOR

4 classroom sham air purifiers and school integrated pest management

Other: integrated pest management

Interventions

integrated pest management and environmental strategy

Environmental InterventionSham and Integrated Pest Management

air purifiers

Active Air Purifier and ControlEnvironmental Intervention

sham air purifiers

Sham and Control

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • grades K-8 with asthma attending sampling/intervention schools

You may not qualify if:

  • moving schools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

FiltrationChemistry Techniques, AnalyticalInvestigative TechniquesEquipment and Supplies

Results Point of Contact

Title
Dr. Wanda Phipatanakul
Organization
Boston Children's Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

May 21, 2013

First Posted

August 1, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

June 7, 2022

Results First Posted

October 14, 2015

Record last verified: 2022-06

Locations