Airways symptoms of exposure to cold air
| ISRCTN | ISRCTN13484593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13484593 |
| Secondary identifying numbers | Version 3 |
- Submission date
- 05/04/2017
- Registration date
- 19/04/2017
- Last edited
- 08/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Exposure to cold air is associated with increased morbidity (disease) and mortality (death) in the
general population. Exposure to extreme cold weather can cause shivering, tiredness, changes in breathing. It can lead to hypothermia (which means their body temperature drops to dangerously low levels) and hypoventilation (slow breathing). It is difficult to study effects of whole-body exposure to cold air under controlled conditions in real life due to safety issues. The aim of this study is to develop a controlled setup to allow investigation of human airway responses of exposures to subfreezing temperatures and compare the impact of the weather on participants with different respiratory issues.
Who can participate?
Adults aged 18 and older who are either healthy, have allergies, are asthmatic, have COPD or are elite skiers.
What does the study involve?
Participants undergo an exercise test to predict their maximum rate that they use oxygen during exercise. Participants are randomly allocated to be exposed to the either 0 °C, -10 °C and -20 °C over three separate sessions at least one week apart. Each exposure session consists of alternating 15 minute periods of upright resting and walking for one hour on a treadmill at a speed that is predicted to cause participants to use 50% of their maximum oxygen levels. General and airway symptoms are recorded using participant interviews during the exposures sessions.
What are the possible benefits and risks of participating?
There are no direct benefits with participating. There is a risk of developing common temporary symptoms associated with exposure to cold air such as rhinorrea (runny or stuffed nose), dyspnea (difficulty breathing), cough, and a general feeling of cold.
Where is the study run from?
Östersund Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2015 to December 2018
Who is funding the study?
1. Gunhild och Assar Karlssons Donations Fund (Sweden)
2. Region Jämtland Härjedalen (Sweden)
Who is the main contact?
Dr Nikolai Stenfors
nikolai.stenfors@gapps.umu.se
Contact information
Scientific
Östersund Hospital
Kyrkgatan 16
Östersund
83183
Sweden
 ORCID ID |
0000-0002-1684-1301 |
|---|---|
| Phone | +46 70 6092778 |
| nikolai.stenfors@gapps.umu.se |
Study information
| Study design | Randomised double-blind cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | ISRCTN13484593_PIS_07Apr17_Swedish.pdf |
| Scientific title | A qualitative study of airways symptoms of experimental exposure to cold air |
| Study hypothesis | 1. Experimental exposure to cold air induces airway symptoms 2. The airway symptoms are correlated to exposure temperature 3. Visavi symptoms, healthy subjects differ from subjects with allergic rhinitis and/or obstructive lung disease |
| Ethics approval(s) | Regional Ethical Review Board Umeå University, 2015-10-06, ref: dnr 2015/245-31 |
| Condition | Allergic rhinitis, asthma, COPD |
| Intervention | Participants undergo a ramped maximum exercise test on a motorised treadmill to predict their maximum oxygen consumption (VO2max). Participants are allocated to one of five groups based on their diagnoses or their specifications. 1. Healthy group 2. Allergic rhinitis group 3. Asthma group 4. COPD group 5. Elite Skier group Participants in each of the groups are randomly exposed to either a 0 °C, -10 °C and -20 °C environmental chamber over three separate occasions at least one week apart. Each exposure session consists of alternating 15 minute periods of upright resting and walking for one hour on a treadmill at a speed that is predicted to elicit 50% of the participants VO2max. Participants are monitored for their general and airway symptoms through participant interviews during each of the exposures. |
| Intervention type | Other |
| Primary outcome measure | General and airways symptoms are recorded by focused open interviews (symptom intensity is measured using the Borg CR10 scale) at session one, two and three. |
| Secondary outcome measures | Group comparison of airway symptoms are measured using focused open interviews using the Borg CR10 scale at session one, two and three. |
| Overall study start date | 01/01/2015 |
| Overall study end date | 01/05/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 8-20 in each group |
| Participant inclusion criteria | Healthy group: 1. Non-smokers 2. No allergy or respiratory disease 3. Not on medication 4. Aged 18 and older Allergic rhinitis group: 1. Non-smokers 2. Symptoms of allergy to common airborne allergens 3. Positive skin prick test 4. Aged 18 and older Asthma group: 1. Non-smoker 2. Physician-diagnosed asthma (stable) 3. Regular use of asthma medications in the past three months 4. Aged 18 and older COPD group: 1. Physician diagnosed COPD 2. Current or former smoker (at least ten pack years) 3. FEV1/FVC <0.7 and FEVI <80% of predicted post bronchodilation 4. Daily use of COPD pharmacotherapy for the last three months 5. Aged 18 and older Elite Skier group: 1. Competitive skiers 2. >400 training hours/year 3. No allergy or asthma 4. Aged 18 and older 5. Non-smokers |
| Participant exclusion criteria | Recent airway infection |
| Recruitment start date | 01/01/2016 |
| Recruitment end date | 28/02/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Östersund
83183
Sweden
Sponsor information
University/education
901 87
Umeå
90187
Sweden
"ROR" |
https://ror.org/05kb8h459 |
|---|
Funders
Funder type
Charity
No information available
No information available
Results and Publications
| Intention to publish date | 01/10/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to a requirement in the ethical approval there is statement that the data would not be shared to unauthorised persons. The dataset will be held at a server at Umeå University. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 07/04/2017 | 19/04/2017 | No | Yes | |
| Results article | results | 01/12/2019 | 08/04/2019 | Yes | No |
Additional files
- ISRCTN13484593_PIS_07Apr17_Swedish.pdf
- Uploaded 19/04/2017
Editorial Notes
08/04/2019: Publication reference added.
07/11/2018: The following changes were made:
1. The recruitment end date was changed from 01/10/2018 to 28/02/2018.
2. The overall trial end date was changed from 31/12/2018 to 01/05/2018.
3. The intention to publish date was changed from 01/09/2018 to 01/10/2018.
14/11/2017: The intention to publish date has been updated from 01/05/2017 to 01/09/2018.
