AsthmaAPACCNCT03406351

Air Pollution, Asthma and Circadian Clocks

An observational study of Asthma and Healthy, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Asthma, Healthy
What is being tested?: Observational
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2018to Jan 2028
Phase: Observational
Are there results?: Not yet: the study is under way

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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Cohort 1: asthmatic patients (case); Cohort 2: matched healthy volunteers (control).

Who may be able to join

>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.

Who cannot join

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),

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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 between exposure to air pollutants and exacerbations (worsening) of pre-existing asthma, incidence of nighttime asthma, difficulties with asthma control and increased disease risk. In 2012, the Public Health Management Corporation's Community Health Data Base estimated that 19.4% of adults in Philadelphia had asthma compared to a national prevalence of 7%.

Asthma has a clear temporal signal. A majority of asthma patients, up to 75%, reports nighttime awakenings due to worsened cough, wheeze and dyspnea. This time-of-day-dependent exacerbation of symptoms, coined nocturnal asthma, is associated with poorer disease control, more frequent medication, and higher asthma-related morbidity and mortality. Consequently, several pathophysiological mechanisms proposed for nocturnal asthma relate to circadian clock biology.

Lung function oscillates over the course of 24 hours, peaking around noon and reaching its nadir during early morning hours. Concentrations of air pollutants show oscillating patterns in urban settings.

In this clinical research study, the investigators start to address how spatiotemporal fluctuations in air pollutants relate to asthma. Mechanistically, the investigators wish to address the hypothesis that microRNAs (miRs) act as interface between asthma phenotypes, circadian clocks and environmental exposure.

Conditions: Asthma, Healthy
Being tested: Observational
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ObservationalOther
Observational deep phenotyping physiological readouts

Study groups in NCT03406351
Study group	Role	What they receive
Asthma		Not described Receives: Other: Observational
Healthy		Matched controls Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in expression levels of miR-142-3p in induced sputum from asthmatics versus controls
Relative expression normalized to housekeeping genes (GAPDH, ACTB) plotted by Expression levels of miR-142-3p will be averaged from several measurements (morning, afternoon, evening, night with target times of 08:00, 14:00, 20:00, 02:00 +/- 1 hour) scheduled over 48 hours
Measured: 48 hours

Secondary outcomes (4)

Concentration of ozone
Concentrations of this air pollutant will be averaged in increments of one hour over the course of 48 hours
Measured: 48 hours
Concentration of the air pollutants CO, CO2, formaldehyde, particulate matter (PM) 1, PM2, PM10, tVOC (total volatile organic compounds)
Concentrations of these air pollutants will be averaged in increments of one hour over the course of 48 hours
Measured: 48 hours
Disease expression of asthma measured how frequent asthma medication is used
The number of uses of asthma medication will determine severity of asthma
Measured: 4 weeks
Circadian phase of cortisol
Concentrations of cortisol in saliva will be determined in the morning, afternoon, evening, and night with target times of 08:00, 14:00, 20:00, 02:00 +/- 1 hour scheduled over 48 hours. Cosinor analysis will determine the circadian phase.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 2018Jan 2028

First posted23 Jan 2018
Study start15 Jan 2018
Primary completionJan 2027 (estimated)
Study completionJan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03406351
Sponsor's protocol ID: IRB828728
Acronym: APACC
Status last verified: Jan 2026
First submitted: 14 Jan 2018
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: To be determined

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
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Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Air Pollution, Asthma and Circadian Clocks
ClinicalTrials.gov ID: NCT03406351
Acronym / sponsor ID: APACC / IRB828728
Conditions: Asthma, Healthy
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 15 Jan 2018 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Jan 2028 (estimated)
First posted: 23 Jan 2018 (actual)
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.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Asthma	–	Other: Observational
Healthy	–	Other: ObservationalMatched controls

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Cohort 1: asthmatic patients (case); Cohort 2: matched healthy volunteers (control).

Key inclusion criteria (6 listed)

>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,

Key exclusion criteria (16 listed)

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,

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
ObservationalObservational deep phenotyping physiological readouts	Other	Asthma, Healthy

Primary outcome

Difference in expression levels of miR-142-3p in induced sputum from asthmatics versus controls
Time frame: 48 hours
Relative expression normalized to housekeeping genes (GAPDH, ACTB) plotted by Expression levels of miR-142-3p will be averaged from several measurements (morning, afternoon, evening, night with target times of 08:00, 14:00, 20:00, 02:00 +/- 1 hour) scheduled over 48 hours

4 secondary outcomes

Concentration of ozone
Time frame: 48 hours
Concentration of the air pollutants CO, CO2, formaldehyde, particulate matter (PM) 1, PM2, PM10, tVOC (total volatile organic compounds)
Time frame: 48 hours
Disease expression of asthma measured how frequent asthma medication is used
Time frame: 4 weeks
Circadian phase of cortisol
Time frame: 48 hours

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Researcher Carsten Skarke, MDLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. To be determined

Related trials for Asthma

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

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.

Garret FitzGerald, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Healthy, run by University of Pennsylvania at 1 site in United States.

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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Difference in expression levels of miR-142-3p in induced sputum from asthmatics versus controls (time frame: 48 hours). 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 NCT03406351.

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 23 Jan 2026.