Statins Against Bushfire Smoke
NCT07462715, Phase 4, Not yet recruiting, Menzies Institute for Medical Research
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Statins Against Bushfire Smoke | ClinicalTrials.gov |
| NCT number | NCT07462715 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Menzies Institute for Medical Research | ClinicalTrials.gov |
| Conditions | Healthy Adults | ClinicalTrials.gov |
| Interventions | Atorvastatin, Placebo | ClinicalTrials.gov |
| First posted | 2026-03-10 | ClinicalTrials.gov |
| Last updated | 2026-03-10 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in heart rate variability (HRV) associated with smoke exposure in the groups treated with statins, compared with the groups not treated with statins. | HRV is measured on two occasions at least 4 weeks apart, one with 2 hours of smoke exposure and one with 2 hours of filtered air exposure. The measurement is continuous over three hours including the half hour before and after the environmental exposure. | Heart rate variability measured as (1) Standard Deviation of Normal-to-Normal intervals (SDNN) and Root Mean Square of Successive Differences (RMSSD). | ClinicalTrials.gov |
| Secondary | Change in blood pressure (BP) associated with smoke exposure in the group treated with statins, compared with the group not treated with statins. | BP is measured 15 minutely for 3 hours on two occasions at least 4 weeks apart. Once incorporating 2 hours of smoke exposure and once incorporating 2 hours of filtered air exposure. | Non invasive, ambulant brachial BP is measured using the ABPM-Pro. The first baseline measure is taken a rest with the third of three measures recorded. Thereafter results from a single measurement are recorded every 15 minutes. | ClinicalTrials.gov |
| Secondary | Change in aortic vascular stiffness associated with smoke exposure in the group treated with statins, compared with the group not treated with statins. | PWV is measured on two occasions at least 4 weeks apart, one immediately following 2 hours of smoke exposure and the other following 2 hours of filtered air exposure. | Aortic vascular stiffness is asses by measuring pulse wave velocity (PWV). PWV from the carotid to the femoral artery is measured with a Sphygmo-cor device using with a carotid tonometer and a femoral BP cuff. | ClinicalTrials.gov |
| Secondary | Difference in Oxidised Low-Density Lipoprotein (oxLDL) Levels Following Clean Air vs. Simulated Bushfire Smoke Exposure in Participants Treated with Statins Compared to Those Not Treated with Statins | Following each 2-hour exposure session (clean air and simulated bushfire smoke), with sessions separated by at least 4 weeks. | Oxidised low-density lipoprotein (oxLDL) is a biomarker of oxidative stress and inflammation. Blood samples will be collected following each 2-hour exposure session (clean air and simulated bushfire smoke) to measure oxLDL levels. Changes in oxLDL between the clean air and simulated bushfire smoke conditions will be compared between participants currently treated with statins and those not treated with statins, to assess whether statin use modifies the oxidative stress response to bushfire smoke exposure. | ClinicalTrials.gov |
| Secondary | Difference in High-Sensitivity C-Reactive Protein (hsCRP) Levels Following Clean Air vs. Simulated Bushfire Smoke Exposure in Participants Treated with Statins Compared to Those Not Treated with Statins | Following each 2-hour exposure session (clean air and simulated bushfire smoke), with sessions separated by at least 4 weeks. | High-sensitivity C-reactive protein (hsCRP) is a biomarker of systemic inflammation and oxidative stress. Blood samples will be collected following each 2-hour exposure session (clean air and simulated bushfire smoke) to measure hsCRP levels. Changes in hsCRP between the clean air and simulated bushfire smoke conditions will be compared between participants currently treated with statins and those not treated with statins, to assess whether statin use modifies the inflammatory response to bushfire smoke exposure. The two exposure sessions are separated by a minimum washout period of at least 4 weeks. | ClinicalTrials.gov |
| Secondary | Difference in Soluble Intercellular and Vascular Cell Adhesion Molecule Levels (sICAM-1 and sVCAM-1) Following Clean Air vs. Simulated Bushfire Smoke Exposure in Participants Treated with Statins Compared to Those Not Treated with Statins | Following each 2-hour exposure session (clean air and simulated bushfire smoke), with sessions separated by at least 4 weeks. | Soluble intercellular adhesion molecule-1 (sICAM-1) and vascular cell adhesion molecule-1 (sVCAM-1) are biomarkers of vascular inflammation and endothelial activation. Blood samples will be collected following each 2-hour exposure session (clean air and simulated bushfire smoke) to measure sICAM-1 and sVCAM-1 levels. Changes in these markers between the clean air and simulated bushfire smoke conditions will be compared between participants currently treated with statins and those not treated with statins, to assess whether statin use modifies the vascular inflammatory response to bushfire smoke exposure. The two exposure sessions are separated by a minimum washout period of at least 4 weeks. | ClinicalTrials.gov |
| Secondary | Difference in Serum Amyloid A (SAA) Levels Following Clean Air vs. Simulated Bushfire Smoke Exposure in Participants Treated with Statins Compared to Those Not Treated with Statins. | Following each 2-hour exposure session (clean air and simulated bushfire smoke), with sessions separated by at least 4 weeks | Serum amyloid A (SAA) is a major acute-phase protein and highly sensitive biomarker of inflammation. Blood samples will be collected following each 2-hour exposure session (clean air and simulated bushfire smoke) to measure SAA levels. Changes in SAA between the clean air and simulated bushfire smoke conditions will be compared between participants currently treated with statins and those not treated with statins, to assess whether statin use modifies the acute-phase inflammatory response to bushfire smoke exposure. The two exposure sessions are separated by a minimum washout period of at least 4 weeks. | ClinicalTrials.gov |
| Secondary | Spatial Working Memory Score as Assessed by the CANTAB Spatial Working Memory Test During Clean Air vs. Simulated Bushfire Smoke Exposure | During the second hour of each 2-hour exposure session (clean air and simulated bushfire smoke) | Spatial working memory will be assessed using the CANTAB Spatial Working Memory (SWM) test, administered on a tablet during the second hour of each 2-hour exposure session. The test requires participants to search through boxes to find hidden tokens, measuring the ability to retain and manipulate spatial information. Outcome metrics include between-errors, strategy scores, and latency. Scores will be compared between the clean air and simulated bushfire smoke exposure sessions | ClinicalTrials.gov |
| Secondary | Cognitive Inhibition and Processing Speed Score as Assessed by the Modified Stroop Test During Clean Air vs. Simulated Bushfire Smoke Exposure | During the second hour of each 2-hour exposure session (clean air and simulated bushfire smoke) | Cognitive inhibition and processing speed will be assessed using the modified Stroop test, administered on a laptop during the second hour of each 2-hour exposure session. Participants are required to identify ink colours while suppressing the reading of incongruent colour words. Outcome metrics include response accuracy and reaction time. Scores will be compared between the clean air and simulated bushfire smoke exposure sessions. | ClinicalTrials.gov |
| Secondary | Self-Reported Anxiety Score as Assessed by the State-Trait Anxiety Inventory (STAI) During Clean Air vs. Simulated Bushfire Smoke Exposure | During the second hour of each 2-hour exposure session (clean air and simulated bushfire smoke) | Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), a validated self-report questionnaire completed during the second hour of each 2-hour exposure session. The STAI consists of two 20-item subscales measuring state anxiety (current feelings) and trait anxiety (general tendency). Each item is rated on a 4-point scale, with total scores ranging from 20 to 80 per subscale; higher scores indicate greater anxiety. Scores will be compared between the clean air and simulated bushfire smoke exposure sessions. | ClinicalTrials.gov |
| Secondary | Postural Stability as Assessed by a Standing Balance Test (Floor and Foam Surfaces, Eyes Open and Closed) During Clean Air vs. Simulated Bushfire Smoke Exposure | During the second hour of each 2-hour exposure session (clean air and simulated bushfire smoke) | Postural stability will be assessed using a short standing balance test administered during the second hour of each 2-hour exposure session. Participants stand quietly at a comfortable foot width under four conditions: floor with eyes open, floor with eyes closed, foam with eyes open, and foam with eyes closed. Outcome metrics include sway and balance performance scores. Results will be compared between the clean air and simulated bushfire smoke exposure sessions | ClinicalTrials.gov |
| Secondary | Symptoms | Collected immediately before and after environmental exposure sessions | Short survey (10 minutes) collecting information about muscular, respiratory and general health symptoms. | ClinicalTrials.gov |
| Secondary | Salivary cortisol | Collected before and after each environmental exposure session | 1 to 1.8 mls of saliva will be collected using the passive drool method for cortisol assay | ClinicalTrials.gov |
| Secondary | Urinary markers of oxidative stress | A total of three samples will be collected. Before and after each environmental exposure session and the first void urine the following morning. | 50ml of urine for measurement of 1-OH-NAP, 2-OH-NAP, and pyrene carboxylic acid | ClinicalTrials.gov |
| Other | Nasopharyngeal Microbiome Composition and Diversity as Assessed by 16S rRNA Sequencing of Nasopharyngeal Swabs Before and After Simulated Bushfire Smoke Exposure | Pre-exposure (baseline) and the day following the 2-hour simulated bushfire smoke exposure session. | Nasopharyngeal swabs will be collected using a COPAN swab placed into eNAT medium and frozen for later sequencing analysis at both exposure visits (clean air and simulated bushfire smoke); however, microbiome analysis will only be performed for the simulated bushfire smoke condition. | ClinicalTrials.gov |
| Other | Previous-Day Dietary Intake as Assessed 24-Hour Dietary Recall (assessed by Food frequency Questionnaire Intake24) During Each Environmental Exposure Visit" | During each 2-hour environmental exposure session (i.e., clean air and simulated bushfire smoke)" | During each 2-hour environmental exposure session (clean air and simulated bushfire smoke), participants will be asked to recall all food and drink consumed in the 24 hours prior to the visit. Dietary data will be collected using Intake24, a validated, self-administered multiple-pass 24-hour dietary recall tool completed on a laptop. The multiple-pass method uses structured prompts to improve accuracy of recall. Intake24 captures food and drink items, portion sizes, and eating occasions, from which nutrient and food group intakes are derived. Dietary data will be used as an exploratory variable to assess whether previous-day dietary intake influences the study outcomes | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Spatial Working Memory | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)