This Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy AdultsPhase 4PINENCT07925229
Pollution, Isotonic Nasal Wash, NSAID Evaluation
A Phase 4 study testing Wood Smoke (Lodgepole Pine) exposure, Filtered Air exposure and Ibuprofen (Advil 400 mg x 4) in people with This Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy Adults, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- This Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy Adults
- What is being tested?
- Wood Smoke (Lodgepole Pine) exposure, Filtered Air exposure and Ibuprofen (Advil 400 mg x 4)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2026to Dec 2029
- Phase
- Phase 4
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 19-65 years, inclusive, with no active respiratory or other medical conditions that may affect study outcomes;
- 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;
- no known hypersensitivity or allergy to Advil (ibuprofen); and
- female participants must be postmenopausal, surgically sterile, or using medically accepted contraception, and must not be pregnant or nursing during the study.
Who cannot join
- Body mass index (BMI) ≥35 kg/m²;
- unable to withhold antihistamines, leukotriene antagonists, immunotherapy, or corticosteroid medications for the duration of the study;
- active medical conditions that may affect respiratory or inflammatory outcomes or increase risk during controlled wood smoke exposure, including asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), active infections, diabetes, long COVID, tuberculosis, or heart conditions;
- 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;
- Are taking other NSAIDs at the time of the active portion of the study;
- high background exposure to air pollution or dust through residence, leisure activities, or occupation; and
- current participation in another research study involving a study drug or controlled exposure, or participation in one within 4-weeks before screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pollution, Isotonic Nasal Wash, NSAID Evaluation (PINE)
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.
- Being tested
- Wood Smoke (Lodgepole Pine) exposure, Filtered Air exposure, Placebo Pill, Ibuprofen (Advil 400 mg x 4)
- Keywords
- Air Pollution, NSAID, Advil, Ibuprofen, Respiratory health, Nasal sampling, Otrivin, Air pollution exposure lab APEL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wood Smoke (Lodgepole Pine) exposureOther
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).
Filtered Air exposureOther
Air will undergo high-efficiency particulate air filtration to generate clean Filtered Air.
Placebo PillDrug
Placebo pills produced to resemble Advil Extra Strength Liqui-Gels will be given at baseline and at 3, 10 and 22 hours following exposures.
Ibuprofen (Advil 400 mg x 4)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Filtered Air exposure with Placebo | Placebo comparator | 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. Receives: Other: Filtered Air exposure; Drug: Placebo Pill |
| Filtered Air exposure with Advil (Ibuprofen) | Experimental | 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. Receives: Other: Filtered Air exposure; Drug: Ibuprofen (Advil 400 mg x 4) |
| Wood Smoke exposure with Placebo | Experimental | 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. Receives: Other: Wood Smoke (Lodgepole Pine) exposure; Drug: Placebo Pill |
| Wood Smoke exposure with Advil (Ibuprofen) | Experimental | 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. Receives: Other: Wood Smoke (Lodgepole Pine) exposure; Drug: Ibuprofen (Advil 400 mg x 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of wood smoke on airway inflammation with Advil and Otrivin: FeNO
Measurement of fractional exhaled nitric oxide (FeNO).
Measured: Comparison of the different arms over the span of 5 months.
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.
Measured: Comparison of the different arms over the span of 5 months.
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.
Measured: Comparison of the different arms over the span of 5 months.
Effects of wood smoke exposure on airflow and resistance in the airways with Advil and Otrivin: Oscillometry
Determine small airways function/resistance using oscillometry.
Measured: Comparison of the different arms over the span of 5 months.
Secondary outcomes (2)
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.
Measured: Comparison of the different arms over the span of 5 months.
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.
Measured: Comparison of the different arms over the span of 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 4-arm randomized crossover human exposure study, with participants acting as their own controls, as they will complete all study arms: Arm A) 2 hours of Filtered Air (FA) exposure with Placebo. Arm B) FA with Advil (400mg at baseline, 3, 10 and 22 hours after each exposure). C) 2 hours of wood smoke (WS), standardized to 500µg/m3 of PM2.5, exposure with Placebo. And Arm D) WS with Advil. Otrivin Sea Water and Aloe Moderate nasal spray will be sprayed into one nostril (randomized for each participant, but kept the same throughout the study) immediately before and after each exposure, and at 24h. The study arms will be separated by 4-week washout periods.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- HALEON
- Responsible party
- Principal investigator, Christopher Carlsten, University of British Columbia
- Investigators
- Chris Carlsten, MD, MPH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925229
- Sponsor's protocol ID
- H26-01337
- Other IDs
- 400326
- Acronym
- PINE
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pollution, Isotonic Nasal Wash, NSAID Evaluation (PINE)
- ClinicalTrials.gov ID
- NCT07925229
- Acronym / sponsor ID
- PINE / H26-01337
- Keywords
- Air Pollution, NSAID, Advil, Ibuprofen, Respiratory health, Nasal sampling, Otrivin, Air pollution exposure lab APEL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- HALEON
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Nov 2026 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a 4-arm randomized crossover human exposure study, with participants acting as their own controls, as they will complete all study arms: Arm A) 2 hours of Filtered Air (FA) exposure with Placebo. Arm B) FA with Advil (400mg at baseline, 3, 10 and 22 hours after each exposure). C) 2 hours of wood smoke (WS), standardized to 500µg/m3 of PM2.5, exposure with Placebo. And Arm D) WS with Advil. Otrivin Sea Water and Aloe Moderate nasal spray will be sprayed into one nostril (randomized for each participant, but kept the same throughout the study) immediately before and after each exposure, and at 24h. The study arms will be separated by 4-week washout periods.
| Arm | Type | Receives |
|---|---|---|
| Filtered Air exposure with Placebo | Placebo comparator | Other: Filtered Air exposure, Drug: Placebo PillParticipants 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. |
| Filtered Air exposure with Advil (Ibuprofen) | Experimental | Other: Filtered Air exposure, Drug: Ibuprofen (Advil 400 mg x 4)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. |
| Wood Smoke exposure with Placebo | Experimental | Other: Wood Smoke (Lodgepole Pine) exposure, Drug: Placebo PillParticipants 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. |
| Wood Smoke exposure with Advil (Ibuprofen) | Experimental | Other: Wood Smoke (Lodgepole Pine) exposure, Drug: Ibuprofen (Advil 400 mg x 4)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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults aged 19-65 years, inclusive, with no active respiratory or other medical conditions that may affect study outcomes;
- 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;
- no known hypersensitivity or allergy to Advil (ibuprofen); and
- female participants must be postmenopausal, surgically sterile, or using medically accepted contraception, and must not be pregnant or nursing during the study.
Key exclusion criteria (7 listed)
- Body mass index (BMI) ≥35 kg/m²;
- unable to withhold antihistamines, leukotriene antagonists, immunotherapy, or corticosteroid medications for the duration of the study;
- active medical conditions that may affect respiratory or inflammatory outcomes or increase risk during controlled wood smoke exposure, including asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), active infections, diabetes, long COVID, tuberculosis, or heart conditions;
- 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;
- Are taking other NSAIDs at the time of the active portion of the study;
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 |
|---|---|---|
| Wood Smoke (Lodgepole Pine) exposureWoodsmoke 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). | Other | Wood Smoke exposure with Advil (Ibuprofen), Wood Smoke exposure with Placebo |
| Filtered Air exposureAir will undergo high-efficiency particulate air filtration to generate clean Filtered Air. | Other | Filtered Air exposure with Advil (Ibuprofen), Filtered Air exposure with Placebo |
| Placebo PillPlacebo pills produced to resemble Advil Extra Strength Liqui-Gels will be given at baseline and at 3, 10 and 22 hours following exposures. | Drug | Filtered Air exposure with Placebo, Wood Smoke exposure with Placebo |
| Ibuprofen (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. | Drug | Filtered Air exposure with Advil (Ibuprofen), Wood Smoke exposure with Advil (Ibuprofen) |
Primary outcome
Effects of wood smoke on airway inflammation with Advil and Otrivin: FeNO
Time frame: Comparison of the different arms over the span of 5 months.
Measurement of fractional exhaled nitric oxide (FeNO).
Effects of wood smoke on airway inflammation with Advil and Otrivin: Cytokines and Oxylipins
Time frame: Comparison of the different arms over the span of 5 months.
An inflammation matrix will be generated, including data from nasal inflammatory cytokines and oxylipins, with independent collection from each nostril.
Effects of wood smoke exposure on airflow and resistance in the airways with Advil and Otrivin: PNIF
Time frame: Comparison of the different arms over the span of 5 months.
Measure nasal patency using peak nasal inspiratory flow (PNIF) analysis.
Effects of wood smoke exposure on airflow and resistance in the airways with Advil and Otrivin: Oscillometry
Time frame: Comparison of the different arms over the span of 5 months.
Determine small airways function/resistance using oscillometry.
2 secondary outcomes
Effects of wood smoke on airway symptoms and perception with Advil and Otrivin
Time frame: Comparison of the different arms over the span of 5 months.
Effects of wood smoke on systemic inflammatory responses with Advil and Otrivin
Time frame: Comparison of the different arms over the span of 5 months.
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 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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.
Chris Carlsten, MD, MPH principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wood Smoke (Lodgepole Pine) exposure, Filtered Air exposure and Ibuprofen (Advil 400 mg x 4) in people with This Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy Adults, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Nov 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 Canada. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Aliza Chow, MA (604-875-5132, aliza.chow@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of wood smoke on airway inflammation with Advil and Otrivin: FeNO (time frame: Comparison of the different arms over the span of 5 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2026.