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Not yet recruitingNCT07665203HEROIC-CFUpdated Jun 24, 2026

Home Air Pollution in Children With Cystic Fibrosis Study

An observational study in Cystic Fibrosis (CF), sponsored by Seattle Children's Hospital. Not yet recruiting. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Seattle Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
6 Years to 18 Years
Sex
All
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Study summary

Cystic Fibrosis (CF) is a devastating chronic pulmonary disease that continues to cause significant morbidity and mortality despite great advances in therapies. Hispanic children with CF have worse outcomes, including higher mortality and more severe pulmonary disease, than non-Hispanic white children with CF. It is not known why Hispanic children with CF have more severe disease as it is not explained by CFTR genetic severity, diagnosis age, or socioeconomic status. The health disparities have worsened, not improved, for Hispanic children with CF since the development of new disease-altering therapeutics, CFTR modulators. It is critical to determine what is contributing to lung disease severity in Hispanic children with CF. Non-genetic factors, including environmental exposures, are estimated to account for 50% of lung disease severity variability in CF. Air pollution exposure during early childhood is associated with lower pulmonary function in healthy children and severe lung disease in children with asthma. However, air pollution exposure is vastly understudied in other chronic pulmonary diseases of childhood, such as CF. Investigating air pollution exposure in CF may provide vital information about the drivers of health disparities in Hispanic children with CF and about the environmental exposures influencing lung disease severity across all children with CF. To investigate air pollution exposure in children with CF, the investigators have assembled a multidisciplinary team of international experts in air pollution exposure, CF lung disease, health disparities, and pulmonary microbiome. The investigators will use two phenomenally rich databases, the CF Foundation Patient Registry and the University of Washington Spatiotemporal Air Pollution Exposure Model, to investigate the first aim: 1A) To determine whether neighborhood-level ambient air pollution exposure during childhood differs between 1500 Hispanic and 8500 non-Hispanic white cwCF in the CF Foundation Patient Registry, and 1B) To determine if neighborhood-level ambient air pollution exposure is associated with lung disease severity in Hispanic and non-Hispanic white cwCF. Across six geographically diverse clinical research CF centers, the investigators will enroll 100 Hispanic and 100 non-Hispanic children with CF to investigate the following aims: 2) To assess differences in residential indoor and ambient air pollution exposures by ethnicity in 200 cwCF, as well as the association between such exposure and pulmonary function by ethnicity, 3) To investigate the association of indoor and ambient air pollution exposure on airway inflammation and microbiome diversity and composition in Hispanic and non-Hispanic white cwCF using metatranscriptomic RNA sequencing. The HEROIC-CF Study is poised to advance the knowledge of the effect of air pollution exposure on not only CF lung disease severity, but may be a model to understand environmental exposures on disease severity in other chronic pulmonary diseases of childhood.

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Conditions studied

  • Cystic Fibrosis (CF)

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Keywords

  • cystic fibrosis
  • air pollution
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In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's planned enrollment of 200 is above the median of 85 across 482 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children with confirmed cystic fibrosis

Inclusion criteria

  • Age 6 to 18 years old
  • Hispanic of any race or non-Hispanic white
  • Diagnosed with cystic fibrosis

Exclusion criteria

Exclusion Criteria:

  • Cannot perform spirometry
  • Planning to move in next 12 months
  • Spends \<4 nights a week in one residence
  • Active smoking in the home
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Indoor Air Pollution

    Measurement of PM2.5 indoors via PurpleAir monitors

    Time frame: 12 Months

Secondary outcomes

  1. Pulmonary Function

    Pulmonary Function Test (PFT) using spirometry: FVC, FEV1, FEV1/FVC, and FEF25%-75%

    Time frame: 12 months

  2. Airway inflammation

    Airway inflammation will be measured using sequencing of oropharyngeal swabs

    Time frame: 12 months

  3. Airway microbiome

    Airway microbiome will be measured using sequencing of oropharyngeal swabs

    Time frame: 12 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07665203
Lead sponsor
Seattle Children's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Meghan McGarry (Associate Professor of Pediatrics, Seattle Children's Hospital) — Principal investigator
First posted
Jun 24, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Apr 30, 2031 (estimated)
Completion
Apr 30, 2031 (estimated)
Last update
Jun 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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