Asthma Clinical Trial
— UltrafineOfficial title:
THE ULTRAFINE PROJECT - A Study of Acute Health Effects of Exposure to Particles Generated by Candles and Cooking
NCT number | NCT04315740 |
Other study ID # | 191100 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | December 20, 2019 |
Verified date | March 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
People spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. Particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution. The overall aim of the present project is to contribute to increased understanding of the association between indoor particulate air pollution and health and well-being.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 20, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 25 Years |
Eligibility | Inclusion Criteria: - Aged 15-25 - Medically treated / physician diagnosed mild seasonal asthma - Never smoker or ex-smoker = 6 months - Allergy > 1 common allergy Exclusion Criteria: - Any other disease that could influence the study parameters - Conditions that prevent safe access to the climate chambers (such as claustrophobia) - Perennial asthma - Need for continuous medical treatment for asthma - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Denmark | Climate Chambers, Dept. Public Health, Aarhus University | Aarhus | Central Region Denmark |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Particles in Exhaled Air (Surfactant Protein A & Albumin) | PExA: Subjects performed repeated breath maneuvers allowing for airway closure and re-opening, and exhaled particles were optically counted and collected on a membrane using the (novel) PExA® instrument set-up. | Time Frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours) | |
Secondary | Change in Lung Function (FEV1 & FVC) | Spirometry | At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours) | |
Secondary | Change in Fractional exhaled nitric oxide (FENO) | NIOX VERO system; Aerocrine AB, Sweden | At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours) | |
Secondary | Change in Blood samples | Cytokines (IL-8), DNA-damages | At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours) | |
Secondary | Change in nasal volume (using Acoustic rhinometry) | Is used to assess the nasal cross sectional area and volume. The left and right nasal cavity were studied alternatively until three reproducible measurements were obtained. The minimum cross sectional cavity area was calculated from the means of the measurements. By integration of the area-distance curve, the sum of the volume 2 to 4 (vol2-4) from the nostril was determined on both sides. | At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours) | |
Secondary | Change in biomarkers in Saliva Sample | An oral svap from Salivette was placed in the mouth of the participant to collect saliva by gently chewing the swab for one minute. Afterwards the saturated swab was removed to the suspended insert and closed firmly with a lid. Then the sample was transferred to a freezer and stored for -80 C until further analysis. The sample will be analyzed for biomarkers (amylase, cortisol, substance P, lysozyme and secretory IgA.) | At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours) | |
Secondary | Change in Subjective Symptoms | In the exposure chamber participants were asked to fill out a symptom questionnaire every 30 minute regarding their well-being and experienced symptoms in eyes, nose and throat. The participants were asked to score their evaluation (rate the strength) of symptoms by placing a cross on a 130 mm open Visual Analogue Scale (VAS). The intensity of any discomfort was registered as the length in mm from the left of the scale to the marker. The scores were rated from 0 to 100% with highest number corresponding to highest discomfort. Health effects were evaluated in relation to rated changes in symptoms. | Every 30 minute during 5 hours of exposure |
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