Status:
ACTIVE_NOT_RECRUITING
Air Pollution, Asthma and Circadian Clocks
Lead Sponsor:
University of Pennsylvania
Conditions:
Asthma
Healthy
Eligibility:
All Genders
18-70 years
Brief Summary
Societies become increasingly urban - more than half the world's population now lives in cities. Urbanization elevates anthropogenic (man-made) exposure to air pollutants. A clear association exists b...
Eligibility Criteria
Inclusion
- \>18 years of age,
- Physician's diagnosis of asthma,
- Prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have at least moderate reversible airways obstruction by their physician),
- severe persistent asthma according to the NHLBI Guidelines,
- evidence of reversible airflow obstruction: (a) forced expiratory volume in 1 second (FEV1) \<80% predicted at the time of or within 3 years of screening, and (b) improvement with bronchodilator: either (i) an increase of ≥15% and 200mL in FEV1 with asthma treatment over the previous 3 years or (ii) after 4 puffs of albuterol by MDI (or 2.5 mg by nebulizer), an increase in FEV1 or FVC ≥12% and 200 mL in FEV1 within 30 min at screening,
- Own a smartphone.
Exclusion
- Severe psychiatric or cognitive problems (obvious mania, schizophrenia, significant mental retardation) making study conduct impossible. Formal psychiatric evaluations are outside of the scope; however, research coordinators will be trained to identify such cases followed by review of the PI. Patients can be referred to mental health facilities.
- Past diagnosis of gastroesophageal reflux disease or obstructive sleep apnea,
- Transmeridian travel across ≥2 time zones in the past month,
- Planned transmeridian travel across more than ≥2 time zones during the planned study activities;
- Use of oral or intravenous antibiotics in the past 6 months,
- Episodes of bronchospasm in response to ultrasonic nebulizer treatment (to induce sputum collection non-invasively),
- Any contraindication listed below in the separate paragraph "Contraindications for the use of CorTemp® Disposable Temperature Sensors";
- Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening;
- \> 2 drinks of alcohol per day;
- Use of illicit drugs;
- Smoking;
- Pregnant or nursing;
- Avoid over-the-counter NSAID use 2 weeks prior to 48 hour session \& during 48 hour session (Visit 3, Visit 4 \& Visit 5);
- Avoid Alcohol use 2 weeks prior to the 48 hour session and during the 3 day session (Visit 3, Visit 4 \& Visit 5);
- Vitamins use 1 week prior to and during the 48 hour session.
- BMI \> 30.
Key Trial Info
Start Date :
January 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03406351
Start Date
January 15 2018
End Date
January 1 2028
Last Update
January 20 2025
Active Locations (1)
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1
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104