Childhood Asthma Reduction Study

NCT01468805 | Withdrawn

• 2 other identifiers: 11023011-E-0230
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: \- Cockroach allergies are an important risk factor for asthma in inner-city households, especially in children. A new method for killing cockroaches may help children who live in households that have high numbers of cockroaches. Because most public health treatments target more than just cockroaches, this method could lower the costs of treating childhood allergies and asthma by focusing on the most likely source of the allergy. Objectives: \- To test a new cockroach-killing method designed to reduce asthma in children exposed to cockroaches. Eligibility:

• Children 5 to 14 years of age who have moderate to severe asthma.
• Children must live in a household that has a high number of cockroaches. Design:
• Participants will be screened with a phone call and an initial home visit.
• Study doctors will place cockroach traps, and return after 3 days to check the number of roaches caught and killed. Dust samples will be collected from the house.
• Participants will have blood and lung function tests, and will be tested for allergies (including cockroach allergies).
• Some households will be treated for cockroaches at regular intervals, or more frequently if required by the study doctors.
• Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and 12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma symptoms. The home visits will also check the cockroach levels in the house.

Conditions

Asthma

Keywords

Environmental Intervention; Indoor Allergens; Cockroach; Health Disparities; Multi-Center; Asthma; Environment

Outcome Measures

Primary Outcomes (1)

• Change in the mean number of maximum asthma symptom days.

Secondary Outcomes (1)

• Asthma-related medical care resource utilization, Lung function, Medication use, Cockroach Number and Allergen Reductions.

Interventions

Cockroach mitigation/extermination PROCEDURE

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A child will be included in this study if the following criteria apply:
• (Assessed during phone screening)
• Aged 5 to 14 years of age
• Physician diagnosis of asthma for at least one year prior to prescreening
• Parent/guardian able and willing to provide consent; child able and willing to provide assent
• Primary caretaker and child are able to speak English or Spanish
• Moderate to severe asthma as defined by the child experiencing one of the following:
• One overnight hospitalization for asthma within the past 6 months,
• Two unscheduled clinic or emergency department visits for asthma within the past 12 months
• Sleeps in the target home greater than or equal to 5 nights per week
• (Assessed at beginning of enrollment/baseline visit)
• Target home has greater than or equal to 30 cockroaches trapped in a 3 day period
• Positive ImmunoCAP Rapid test result to cockroach allergen

You may not qualify if:

• A child will be excluded from this study if the following criteria apply, as determined in the screening phone call and/or confirmed at the baseline visit:
• The child has other serious medical or chronic illnesses, other than asthma, such as:
• Any hematologic, metabolic/endocrine, respiratory (other than asthma), cardiac or neurologic disorder requiring daily medications;
• Any severe behavioral problem that prohibits the child or the child s caregiver from answering questions or following instructions;
• Any autoimmune disease including rheumatoid arthritis, lupus, and myositis;
• Any immune deficiency;
• Any other serious medical condition such as juvenile diabetes mellitus, hypothyroidism, hyperthyroidism, cerebral palsy, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis.
• Plans to move within the 12 months of study enrollment
• Has no caregiver with access to a phone
• Sibling or other household member currently participating in the study.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Darryl C Zeldin, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 10, 2011
• First Posted: November 10, 2011
• Study Start: September 4, 2011
• Primary Completion: November 15, 2013
• Study Completion: November 15, 2013
• Last Updated: December 9, 2019

Record last verified: 2013-11-15