Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

Asthma Clinical Trial

Official title:

Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006565
• Other study ID #: 136
• Secondary ID: R01HL065731
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2000
• Last updated: February 17, 2016
• Start date: September 2000
• Est. completion date: April 2004

Study information

• Verified date: October 2008
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effects of reducing indoor environmental tobacco smoke (ETS) on unscheduled asthma visits, asthma symptoms, airway inflammation, and exposure to tobacco smoke measured using air nicotine dosimeters, serum and hair cotinine.

Description:

BACKGROUND:

Asthma, a disease characterized by increased airway reactivity and inflammation in response to a variety of stimuli, is emerging as the most prevalent and serious environmental health problem among children in the United States. Numerous studies, both prospective and cross-sectional, suggest that exposure to ETS is one of the predominate risk factors for childhood asthma, but this has not been confirmed in a controlled trial.

DESIGN NARRATIVE:

The randomized, double-blind prospective trial involving 225 children with doctor-diagnosed asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such exposure on unscheduled asthma visits and asthma symptoms. The intervention consists of placement of 2 high efficiency air filtration with activated carbon, potassium permanganate and zeolite filter insert to reduce exposure to ETS in the experimental homes and inactive (placebo) units in the control group homes. The following hypotheses are tested. (1.0) Children assigned to the ETS reduction group will have a greater than 20 percent reduction in unscheduled asthma visits during one-year follow-up compared with those in the control group. (1.1) Children assigned to the ETS reduction group will have significant improvements in asthma symptoms compared with children in the control group. (1.2) Children assigned to the ETS reduction group will have greater than 10 percent reduction in ETS exposure and exhaled nitric oxide, a measure of airway inflammation during one year of follow-up compared with the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 2004
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age 6-12 years at enrollment

• Doctor diagnosed asthma by ICD-9 billing codes (from billing records)

• Greater than 1 exacerbation(s) in the past year requiring an unscheduled asthma visit

• Exposed to the smoke of greater than or equal to 5 cigarettes in and around the house per day

• Lived within a 9-county area surrounding the city of Cincinnati

Exclusion Criteria:

• Already using a HEPA air cleaner

• Lacked electricity

• Had a coexisting medical problem

• Family planned to move in the next year

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

Intervention

Device:
• HEPA Air Cleaner
Placement of two active HEPA air cleaners in the homes of children
• Placebo Filtration Unit
Placement of inactive filtration unit in the homes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

Spanier AJ, Hornung R, Lierl M, Lanphear BP. Environmental exposures and exhaled nitric oxide in children with asthma. J Pediatr. 2006 Aug;149(2):220-6. — View Citation

Spanier AJ, Hornung RW, Kahn RS, Lierl MB, Lanphear BP. Seasonal variation and environmental predictors of exhaled nitric oxide in children with asthma. Pediatr Pulmonol. 2008 Jun;43(6):576-83. doi: 10.1002/ppul.20816. — View Citation

Wilson SE, Kahn RS, Khoury J, Lanphear BP. Racial differences in exposure to environmental tobacco smoke among children. Environ Health Perspect. 2005 Mar;113(3):362-7. — View Citation

Wilson SE, Kahn RS, Khoury J, Lanphear BP. The role of air nicotine in explaining racial differences in cotinine among tobacco-exposed children. Chest. 2007 Mar;131(3):856-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unscheduled asthma visits		Measured at 12 months	No
Secondary	Asthma symptoms		Measured at 12 months	No
Secondary	Exhaled nitric oxide		Measured at 12 months	No
Secondary	Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine		Measured at 12 months	No