AsthmaPhase 3NCT00006565
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
A Phase 3 study testing HEPA Air Cleaner in people with Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma, Lung Diseases
- What is being tested?
- HEPA Air Cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Apr 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Already using a HEPA air cleaner
- Lacked electricity
- Had a coexisting medical problem
- Family planned to move in the next year
About this study
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.
Read the detailed 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.
- Conditions
- Asthma, Lung Diseases
- Being tested
- HEPA Air Cleaner, Placebo Filtration Unit
- Keywords
- asthma, HEPA, ETS
- Medical subject headings
- Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPA Air CleanerDevice
Also called Austin Healthmate HEPA air cleaner
Placement of two active HEPA air cleaners in the homes of children
Placebo Filtration UnitDevice
Placement of inactive filtration unit in the homes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HEPA Air Cleaners Receives: Device: HEPA Air Cleaner |
| 2 | Placebo comparator | Inactive (placebo) filtration unit Receives: Device: Placebo Filtration Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unscheduled asthma visits
Measured: Measured at 12 months
Secondary outcomes (3)
Asthma symptoms
Measured: Measured at 12 months
Exhaled nitric oxide
Measured: Measured at 12 months
Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine
Measured: Measured at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2000 (estimated)
- Study startSep 2000
- Primary completionMar 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Bruce P Lanphear, MD, MPH, Principal investigator, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006565
- Sponsor's protocol ID
- 136
- Other IDs
- R01HL065731
- Status last verified
- Oct 2008
- First submitted
- 1 Dec 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1289/ehp.7379.
PubMed 15743729Spanier 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.
PubMed 18429012Spanier 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. doi: 10.1016/j.jpeds.2006.04.001.
PubMed 16887438Wilson 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):856-862. doi: 10.1378/chest.06-2123.
PubMed 17356104Lanphear BP, Hornung RW, Khoury J, Yolton K, Lierl M, Kalkbrenner A. Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. Pediatrics. 2011 Jan;127(1):93-101. doi: 10.1542/peds.2009-2312. Epub 2010 Dec 13.
PubMed 21149427
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
- ClinicalTrials.gov ID
- NCT00006565
- Acronym / sponsor ID
- 136
- Conditions
- Asthma, Lung Diseases
- Keywords
- asthma, HEPA, ETS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Mar 2003 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 1 Dec 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: HEPA Air CleanerHEPA Air Cleaners |
| 2 | Placebo comparator | Device: Placebo Filtration UnitInactive (placebo) filtration unit |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Already using a HEPA air cleaner
- Lacked electricity
- Had a coexisting medical problem
- Family planned to move in the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEPA Air CleanerAlso: Austin Healthmate HEPA air cleanerPlacement of two active HEPA air cleaners in the homes of children | Device | 1 |
| Placebo Filtration UnitPlacement of inactive filtration unit in the homes | Device | 2 |
Primary outcome
Unscheduled asthma visits
Time frame: Measured at 12 months
3 secondary outcomes
Asthma symptoms
Time frame: Measured at 12 months
Exhaled nitric oxide
Time frame: Measured at 12 months
Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine
Time frame: Measured at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Results publication: PubMed 15743729Wilson 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. doi: 10.1289/ehp.7379.
- Results publication: PubMed 18429012Spanier 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.
- Results publication: PubMed 16887438Spanier 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. doi: 10.1016/j.jpeds.2006.04.001.
- Results publication: PubMed 17356104Wilson 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):856-862. doi: 10.1378/chest.06-2123.
- Derived from this study: PubMed 21149427Lanphear BP, Hornung RW, Khoury J, Yolton K, Lierl M, Kalkbrenner A. Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. Pediatrics. 2011 Jan;127(1):93-101. doi: 10.1542/peds.2009-2312. Epub 2010 Dec 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce P Lanphear, MD, MPH principal investigator
Simon Fraser University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HEPA Air Cleaner in people with Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unscheduled asthma visits (time frame: Measured at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006565, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.