ClinicalTrials.gg
Not yet recruitingNCT07925229PINEUpdated Nov 9, 2026

Pollution, Isotonic Nasal Wash, NSAID Evaluation

A Phase 4 interventional study of Wood Smoke (Lodgepole Pine) exposure and Filtered Air exposure in This Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy Adults, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University of British Columbia · Phase 4, Interventional, and Prevention

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study summary

The goal of this clinical exposure study is to investigate the inflammatory and airway responses to controlled wood smoke exposure, a model for wildfire-related air pollution, and how these responses change with Otrivin Natural Saline Nasal Spray and Advil Extra Strength Liqui-Gels 400mg, used within their approved indications for clearing the nasal passages and the relief of pain and inflammation, respectively, in healthy adult participants. The main questions it aims to answer are:

  • How does controlled wood smoke exposure affect airway inflammation, and how does this response change with Advil use?
  • How do the nasal effects of wood smoke exposure change with Otrivin Natural saline nasal spray use? Researchers will compare the effects of wood smoke exposure and these interventions versus filtered air and placebo using a crossover design, where each participant will be compared to themselves. Participants will complete questionnaires, breathing tests, nasal sampling and blood collections before and after each exposure.
Read the detailed description

Wildfire smoke is becoming an increasing source of air pollution and can contain substances that may affect health. Exposure to air pollution, including wildfire smoke, can cause inflammation and irritation in the airways and may contribute to symptoms such as coughing, throat irritation, difficulty breathing, and inflammation or pain in the eyes and nose. However, more research is needed to understand how exposure to wildfire smoke affects the nose and lungs.

Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (the active ingredient in Advil), are commonly used to reduce pain and inflammation. Some previous research suggests that NSAIDs, used as a model anti-inflammatory medication, may reduce certain effects of air pollution exposure. However, it is not yet known whether the inflammation caused by wood smoke, as a model for wildfire-related air pollution, is modulated with Advil use.

It is also not known whether the irritating effects of wood smoke air pollution exposure on the nose are altered when Otrivin is used to wash the nose. The purpose of this study is to investigate how controlled wood smoke exposure affects the nose and lungs and whether Advil and Otrivin saline nasal spray, used within their indications, alter these effects. The information collected in this study may contribute to future research on the health effects of wildfire smoke and potential ways to reduce these effects.

Participants will be asked to complete an initial baseline screening, followed by four study arms, with each study arm consisting of two study visits. During the first visit of each study arm, participants will undergo a controlled 2-hour exposure to either filtered air or wood smoke and will receive either Advil or a placebo. The second visit of each study arm will occur approximately 24 hours after the exposure visit. The four study arms will involve different combinations of exposure and Advil/Placebo, but the order in which the study arms are completed will be determined by chance and not revealed to the participants or the clinical study team. There will be at least 4 weeks between each study arm to allow time for the previous exposure to wash out.

02

Conditions studied

  • This Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy Adults

Keywords

  • Air Pollution
  • NSAID
  • Advil
  • Ibuprofen
  • Respiratory health
  • Nasal sampling
  • Otrivin
  • Air pollution exposure lab APEL
03

In context

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

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

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adults aged 19-65 years, inclusive, with no active respiratory or other medical conditions that may affect study outcomes;
  2. no use of tobacco, vaping devices, or cannabis within the previous 6 months and a lifetime smoking history of less than 0.5 pack-years;
  3. no known or allergy to Advil (ibuprofen); and
  4. female participants must be , surgically sterile, or using medically accepted , and must not be pregnant or nursing during the study.

Exclusion criteria

Exclusion Criteria:

  1. (BMI) ≥35 kg/m²;
  2. unable to withhold antihistamines, leukotriene antagonists, immunotherapy, or medications for the duration of the study;
  3. active medical conditions that may affect respiratory or inflammatory outcomes or increase risk during controlled wood smoke exposure, including asthma, allergic rhinitis, (COPD), active infections, diabetes, long COVID, tuberculosis, or heart conditions;
  4. planned hospitalization(s) or blood donation during the study period; and (e) high background exposure to air pollution or dust through residence, leisure activities, or occupation;
  5. Are taking other NSAIDs at the time of the active portion of the study;
  6. high background exposure to air pollution or dust through residence, leisure activities, or occupation; and
  7. current participation in another research study involving a study drug or controlled exposure, or participation in one within 4-weeks before screening.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Placebo comparator
    Filtered Air exposure with Placebo

    Participants will be exposed to high-efficiency particulate air (HEPA) filtered air for 2 hours, and will take a placebo both before, and 3, 10, 22 hours after.

    Other: Filtered Air exposure · Drug: Placebo Pill

  • Experimental
    Filtered Air exposure with Advil (Ibuprofen)

    Participants will be exposed to high-efficiency particulate air (HEPA) filtered air for 2 hours and will take Advil (Ibuprofen 400mg) both before, and 3, 10 and 22 hours after.

    Other: Filtered Air exposure · Drug: Ibuprofen (Advil 400 mg x 4)

  • Experimental
    Wood Smoke exposure with Placebo

    Participants will be exposed to wood smoke, standardized to 500µg/m3 of PM2.5, for 2 hours and will take a placebo both before, and 3, 10 and 22 hours after.

    Other: Wood Smoke (Lodgepole Pine) exposure · Drug: Placebo Pill

  • Experimental
    Wood Smoke exposure with Advil (Ibuprofen)

    Participants will be exposed to wood smoke, standardized to 500µg/m3 of PM2.5, for 2 hours and will take Advil (Ibuprofen 400mg) both before, and 3, 10 and 22 hours after.

    Other: Wood Smoke (Lodgepole Pine) exposure · Drug: Ibuprofen (Advil 400 mg x 4)

Interventions

  • OtherWood Smoke (Lodgepole Pine) exposure

    Woodsmoke will be freshly generated using a furnace tube burning dried, ground lodgepole pine (Pinus contorta) to achieve a nominal concentration of 500µg/m3 of PM2.5 (particulate matter with an aerodynamic diameter of less than or equal to 2.5 micrometres).

  • OtherFiltered Air exposure

    Air will undergo high-efficiency particulate air filtration to generate clean Filtered Air.

  • DrugPlacebo Pill

    Placebo pills produced to resemble Advil Extra Strength Liqui-Gels will be given at baseline and at 3, 10 and 22 hours following exposures.

  • DrugIbuprofen (Advil 400 mg x 4)

    400mg of the non-steroidal anti-inflammatory drug Ibuprofen in the form of Advil Extra Strength Liqui-Gels given at baseline and at 3, 10 and 22 hours following exposures.

06

What researchers measure

Primary outcomes

  1. Effects of wood smoke on airway inflammation with Advil and Otrivin: FeNO

    Measurement of fractional exhaled nitric oxide (FeNO).

    Time frame: Comparison of the different arms over the span of 5 months.

  2. Effects of wood smoke on airway inflammation with Advil and Otrivin: Cytokines and Oxylipins

    An inflammation matrix will be generated, including data from nasal inflammatory cytokines and oxylipins, with independent collection from each nostril.

    Time frame: Comparison of the different arms over the span of 5 months.

  3. Effects of wood smoke exposure on airflow and resistance in the airways with Advil and Otrivin: PNIF

    Measure nasal patency using peak nasal inspiratory flow (PNIF) analysis.

    Time frame: Comparison of the different arms over the span of 5 months.

  4. Effects of wood smoke exposure on airflow and resistance in the airways with Advil and Otrivin: Oscillometry

    Determine small airways function/resistance using oscillometry.

    Time frame: Comparison of the different arms over the span of 5 months.

Secondary outcomes

  1. Effects of wood smoke on airway symptoms and perception with Advil and Otrivin

    The Symptoms and Perception questionnaire (see https://particleandfibretoxicology.biomedcentral.com/articles/10.1186/s12989-022-00506-6#Sec15) will be completed.

    Time frame: Comparison of the different arms over the span of 5 months.

  2. Effects of wood smoke on systemic inflammatory responses with Advil and Otrivin

    An inflammation matrix will be generated, including data from urinary isoprostanes and eicosanoid metabolites.

    Time frame: Comparison of the different arms over the span of 5 months.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2026
First posted
Nov 9, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2029
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925229
Collaborators
HALEON
Responsible party
Christopher Carlsten (Professor, University of British Columbia) — Principal investigator
First posted
Nov 9, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Nov 9, 2026

Study contacts

Aliza Chow, MA
Contact
aliza.chow@ubc.ca
604-875-5132
Agnes Yuen, BSc
Contact
agnes.yuen@ubc.ca
604-875-4111 ext. 66455
Chris Carlsten, MD, MPH
principal investigator · University of British Columbia

Oversight

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

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