Asthma, Exercise-InducedALASCAIR1NCT03840044
The Effect of Physical Exercise in a Cold Air Environment on Normal Volunteers and Asthmatic Patients
A study testing Cold air exercise test in people with Asthma, Exercise-Induced, run by KU Leuven at 1 site in Belgium.
Trial summary
The purpose of the study is to compare airway physiologic reactions to physical exercise in a cold air environment (-5°C, 60% relative humidity) between normal volunteers and subjects with mild/moderate asthma. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Exercise-Induced
- What is being tested?
- Cold air exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jun 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 60 years at time of signing informed consent
- BMI between 18-28 kg/m2
- able to comply with study protocol, in the investigator's judgement
- non-smoking or ex-smokers for at least 12 months with less than 10 pack years
- no immunoglobulin E (IgE) mediated hypersensitivity
- normal spirometry \& normal ECG at screening
Show all 17Show fewer
- negative histamine provocation (defined as His- if PC20 >/= 8 mg/ml and His+ healthy controls if PC20 > 4 mg/ml and < 8 mg/ml)
- age between 18 and 60 years at time of signing informed consent
- BMI between 18-28 kg/m2
- able to comply with study protocol, in the investigator's judgement
- non-smoking or ex-smokers for at least 12 months with less than 10 pack years
- physician-diagnosed asthma for more than 6 months
- post bronchodilator FEV1 of ≥ 80% at screening
- documented airway reversibility either by means of post bronchodilator reversibility of > 12% and > 200 ml or in the previous 6 months or by means of documented airway hyperresponsiveness (histamine PC20 <8 mg/ml) at screening
- Asthma Control Questionnaire (ACQ) < 1,5
- regular treatment with inhaled corticosteroids (ICS) with or without long-acting beta-agonists (LABA) (unchanged dose for at least 1 month)
- normal ECG at screening
Who cannot join
- physician-diagnosed asthma or history of (post)infectious bronchial hyperreactivity
- major pulmonary or cardiovascular disease
- treatment with β-blockers
- pregnancy
- unable to produce sputum with sputum induction
- previous history of intubation or admission to the intensive care unit due to asthma
Show all 12Show fewer
- severe asthma exacerbation within one year prior to screening visit
- treatment with oral or systemic steroids within one year prior to screening visit
- previous treatment with biologics for asthma
- treatment with β-blockers
- other major concurrent pulmonary (such as chronic obstructive pulmonary disease, cystic fibrosis, sarcoidosis, interstitial lung disease, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, bronchiectasis) or cardiovascular disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to compare airway physiologic reactions to physical exercise in a cold air environment (-5°C, 60% relative humidity) between normal volunteers and subjects with mild/moderate asthma. For this purpose, the investigators intend to evaluate the effect of a cold air exercise test on the Forced Expiratory Volume in 1 second (FEV1), respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome.
This study also features as an exploratory study for a subsequent interventional study in order to establish the feasibility of the cold air exercise protocol and to determine the extent of the effects in subjects with mild/moderate asthma.
Read the detailed description
It is already demonstrated that exercising during cold air exposure and at a high altitude may induce asthmatic symptoms, a variable degree of airway obstruction and increased neutrophilic airway inflammation in asthmatic patients. Therefore, in this project, the investigators want to evaluate the feasibility, of a shorter standardized "cold air exercise test" (a submaximal exercise challenge in a controlled cold air (-5°C, relative humidity 60%) environment) and to compare the respiratory physiologic reactions to physical exercise during cold exposure between healthy volunteers and asthmatic patients. For this purpose, they intend to evaluate the effect of a cold air exercise test on FEV1, respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome.
This study features as an exploratory study for a subsequent interventional study, that will assess the protective effect of azithromycin versus placebo on the cold air exercise induced changes in patients with mild/moderate asthma (ALASCAIR2 study). The present preparatory study is needed to standardize the cold air exercise test in a controlled environment so that it would be possible to use it as challenge test in an interventional study and to identify the most appropriate design for such a study.
The primary objective of this study is to compare the proportional change in FEV1, pre to post a 90 minutes submaximal exercise in a cold air environment between healthy volunteers versus mild/moderate asthmatics, calculated as a time-weighted average over the 30 minutes post-exposure.
The primary endpoint is the change in FEV1, calculated as a time-weighted average over the 30 minutes after the cold exercise test. At each time point (pre-exposure, 5' post-exposure, and at 15, 25 and 35 minutes post-exposure), FEV1 (L) will be measured in triplicate.
They want to evaluate whether the exercise test in a cold air environment produces respiratory symptoms (such as nasal discharge or obstruction, dyspnea, cough and/or mucus production, etc.), has an impact on airway integrity (nasal patency, airflow obstruction, lung ventilation inhomogeneity \& small airway dysfunction, bronchial hyperreactivity, cough reflex hypersensitivity), induces local or systemic inflammatory changes (biomarkers in nasal fluid, sputum and blood) or changes to the airway microbiome (in nasal fluid and sputum) in healthy volunteers and in mild/moderate asthmatics. The study group also want to compare the observed changes induced by the cold air exercise test between the healthy volunteers and the mild/moderate asthmatics.
The secondary endpoints of this study include the observed changes in (respiratory) symptom score, Peak Nasal Inspiratory Flow (PNIF), Forced Vital Capacity (FVC), Forced Expiratory Flow (FEF25-75), Fraction of Exhaled Nitric Oxide (FeNO), histamine provocative concentration causing 20% drop in FEV1 (PC20), cough threshold C2 \& C5, sputum differential cell count, biomarkers in nasal fluid, sputum and blood, nasal and sputum microbial communities between the healthy volunteers and the mild/moderate asthmatics.
- Conditions
- Asthma, Exercise-Induced
- Being tested
- Cold air exercise test
- Keywords
- Asthma, Exercise, Cold air exposure
- Medical subject headings
- Asthma, Exercise-Induced, Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold air exercise testOther
Subjects will perform a submaximal 90 minutes exercise test in a controlled cold air environment (-5°C, 60% relative humidity) in a climate chamber with evaluation pre§/during*/post§ of heart rate (HR)§* and blood pressure (BP)§*, spirometry§*, PNIF§, FeNO§, electrocardiogram (ECG)§*, body \& exhaled air temperature§*, capsaicin cough threshold test§, histamine bronchial challenge test§, and sampling of nasal fluid§, induced sputum§, and venous blood§.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Healthy volunteers will perform the same protocol as foreseen for asthmatic patients. Both will perform the cold air exercise test with pre -and post-exposure evaluation of on FEV1, respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome. Receives: Other: Cold air exercise test |
| Asthmatic subjects | Other | Asthmatic patients will perform the same protocol as foreseen for healthy volunteers. They will perform the cold air exercise test with pre -and post-exposure evaluation of on FEV1, respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome. Receives: Other: Cold air exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in 1 seconds (FEV1)
Change in FEV1, calculated as a time-weighted average over the 35 minutes after the cold air exercise test and 24 hours and 1 week post-exposure. A maximal fall of 10% will be considered as positive response
Measured: pre-, 5, 15, 25 and 35 minutes, 24 hours and 1 week post-exposure
Secondary outcomes (14)
Changes in asthma control
Asthma control will be determined using the Asthma Control Questionnaire (ACQ-6), including 6 questions. Each question will be scored from 0-6 and added together. This final score will be divided by the number of questions. If ACQ-6 < 0.75 = controlled asthma, ACQ-6 from 0.75-1.5 = partly controlled asthma and ACQ-6 > 1.5 = uncontrolled asthma.
Measured: Pre-exposure and immediately, 24 hours and 1 week post-exposure
Changes in respiratory symptom score
The degree of dyspnea will be determined using Borg scale. This Borg scale is 0 to 10 rated scale. With 0 no dyspnea and 10 complete dyspnea.
Measured: Pre-exposure and immediately, 24 hours and 1 week post-exposure
Cough hypersensitivity
Cough hypersensitivity (Capsaicin cough threshold) will be measured using a capsaicin challenge test. The concentrations (µmol/l) which provokes 2 coughs (C2) and 10 coughs (C10) will be recorded and will be compared before and after cold air exposure.
Measured: Pre-exposure and 24 hours and 1 week post-exposure
Bronchial hyperreactivity
Bronchial hyperreactivity will be measured using a histamine provocation. Bronchial hyperreactivity will be confirmed when there is a drop of 20% in FEV1 post histamine provocation (PC20).
Measured: Pre-exposure and 1 week post-exposure
Nasal hyperreactivity
Nasal hyperreactivity will be measured using a PNIF measurement. Nasal hyperreactivity will be confirmed when there is a drop of 20% in PNIF.
Measured: Pre-exposure and immediately and 24 hours post-exposure
Airway inflammation
Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (>3% eosinophils, <61% neutrophils), neutrophilic (<3% eosinophils and >61% neutrophils), pauci-granulocytic (<3% eosinophils and <61% neutrophils) and mixed granulocytic airway inflammation (>3% eosinophils and >61% neutrophils).
Measured: Pre-exposure and 24 hours and 1 week post-exposure
Cytokine pattern in the airways
Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay.
Measured: Pre-exposure and 24 hours and 1 week post-exposure
Biomarkers for airway inflammation
FeNO will be used as biomarker for eosinophilic airway inflammation. FeNO < 25 ppb = eosinophilic inflammation less likely, FeNO between 25 and 50 ppm = need further interpretation with additional clinical information, FeNO > 50 ppm = indication of eosinophilic airway inflammation (according to the American Thoracic Society guidelines)
Measured: Pre-exposure and 24 hours and 1 week post-exposure
Nasal inflammation
Cytokine concentrations (pg/ml) will be determined in the nasal fluid as biomarkers for nasal inflammation
Measured: Pre-exposure and immediately and 24 hours post-exposure
Systemic inflammation
The degree of system inflammation will be determined via differential blood cell count.
Measured: Pre-exposure and immediately, 24 hours and 1 week post-exposure
Biomarkers for systemic inflammation
The degree of system inflammation will be determined via C-reactive protein (CRP) levels. Normal values for CRP are considered < 10 mg/ml.
Measured: Pre-exposure and immediately, 24 hours and 1 week post-exposure
Changes in microbiome in lung and nose
The presence of 22 common respiratory viruses, 5 bacteria and 1 fungi will be determined using qualitative reverse transcription polymerase chain reaction (qRT-PCR) in sputum and nasal fluid. Pre and post-exposure microbiome patterns will be compared.
Measured: Pre-exposure and 1 week post-exposure
Evaluation of the heart rate pattern
Cardiovascular health will be evaluated by determining the heart rate pattern using ECG. Deviation from a normal ECG pattern will be recorded.
Measured: Pre-exposure and during the 90 minutes cold air exposure
Determining the exercise capacity
Exercise capacity will be checked. In a single test pre-exposure, the aerobic heart rate zone, anaerobic heart rate zone and maximal oxygen volume uptake (VO2max) heart rate zone will be evaluated to determine the exercise capacity
Measured: Pre-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start3 Jun 2019
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, Exercise-InducedStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Healthy volunteers will be compared with asthmatic subjects
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatjana Decaesteker, KU Leuven
- Investigators
- Lieven Dupont, Prof. dr, Principal investigator, KU Leuven/ UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840044
- Sponsor's protocol ID
- s61661
- Acronym
- ALASCAIR1
- Status last verified
- Dec 2020
- First submitted
- 23 Jan 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Exercise in a Cold Air Environment on Normal Volunteers and Asthmatic Patients
- ClinicalTrials.gov ID
- NCT03840044
- Acronym / sponsor ID
- ALASCAIR1 / s61661
- Conditions
- Asthma, Exercise-Induced
- Keywords
- Asthma, Exercise, Cold air exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 15 Feb 2019 (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 purpose of the study is to compare airway physiologic reactions to physical exercise in a cold air environment (-5°C, 60% relative humidity) between normal volunteers and subjects with mild/moderate asthma. For this purpose, the investigators intend to evaluate the effect of a cold air exercise test on the Forced Expiratory Volume in 1 second (FEV1), respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome.
This study also features as an exploratory study for a subsequent interventional study in order to establish the feasibility of the cold air exercise protocol and to determine the extent of the effects in subjects with mild/moderate asthma.
Detailed description
It is already demonstrated that exercising during cold air exposure and at a high altitude may induce asthmatic symptoms, a variable degree of airway obstruction and increased neutrophilic airway inflammation in asthmatic patients. Therefore, in this project, the investigators want to evaluate the feasibility, of a shorter standardized "cold air exercise test" (a submaximal exercise challenge in a controlled cold air (-5°C, relative humidity 60%) environment) and to compare the respiratory physiologic reactions to physical exercise during cold exposure between healthy volunteers and asthmatic patients. For this purpose, they intend to evaluate the effect of a cold air exercise test on FEV1, respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome.
This study features as an exploratory study for a subsequent interventional study, that will assess the protective effect of azithromycin versus placebo on the cold air exercise induced changes in patients with mild/moderate asthma (ALASCAIR2 study). The present preparatory study is needed to standardize the cold air exercise test in a controlled environment so that it would be possible to use it as challenge test in an interventional study and to identify the most appropriate design for such a study.
The primary objective of this study is to compare the proportional change in FEV1, pre to post a 90 minutes submaximal exercise in a cold air environment between healthy volunteers versus mild/moderate asthmatics, calculated as a time-weighted average over the 30 minutes post-exposure.
The primary endpoint is the change in FEV1, calculated as a time-weighted average over the 30 minutes after the cold exercise test. At each time point (pre-exposure, 5' post-exposure, and at 15, 25 and 35 minutes post-exposure), FEV1 (L) will be measured in triplicate.
They want to evaluate whether the exercise test in a cold air environment produces respiratory symptoms (such as nasal discharge or obstruction, dyspnea, cough and/or mucus production, etc.), has an impact on airway integrity (nasal patency, airflow obstruction, lung ventilation inhomogeneity \& small airway dysfunction, bronchial hyperreactivity, cough reflex hypersensitivity), induces local or systemic inflammatory changes (biomarkers in nasal fluid, sputum and blood) or changes to the airway microbiome (in nasal fluid and sputum) in healthy volunteers and in mild/moderate asthmatics. The study group also want to compare the observed changes induced by the cold air exercise test between the healthy volunteers and the mild/moderate asthmatics.
The secondary endpoints of this study include the observed changes in (respiratory) symptom score, Peak Nasal Inspiratory Flow (PNIF), Forced Vital Capacity (FVC), Forced Expiratory Flow (FEF25-75), Fraction of Exhaled Nitric Oxide (FeNO), histamine provocative concentration causing 20% drop in FEV1 (PC20), cough threshold C2 \& C5, sputum differential cell count, biomarkers in nasal fluid, sputum and blood, nasal and sputum microbial communities between the healthy volunteers and the mild/moderate asthmatics.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy volunteers will be compared with asthmatic subjects
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Cold air exercise testHealthy volunteers will perform the same protocol as foreseen for asthmatic patients. Both will perform the cold air exercise test with pre -and post-exposure evaluation of on FEV1, respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome. |
| Asthmatic subjects | Other | Other: Cold air exercise testAsthmatic patients will perform the same protocol as foreseen for healthy volunteers. They will perform the cold air exercise test with pre -and post-exposure evaluation of on FEV1, respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- age between 18 and 60 years at time of signing informed consent
- BMI between 18-28 kg/m2
- able to comply with study protocol, in the investigator's judgement
- non-smoking or ex-smokers for at least 12 months with less than 10 pack years
- no immunoglobulin E (IgE) mediated hypersensitivity
Key exclusion criteria (12 listed)
- physician-diagnosed asthma or history of (post)infectious bronchial hyperreactivity
- major pulmonary or cardiovascular disease
- treatment with β-blockers
- pregnancy
- unable to produce sputum with sputum induction
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 |
|---|---|---|
| Cold air exercise testSubjects will perform a submaximal 90 minutes exercise test in a controlled cold air environment (-5°C, 60% relative humidity) in a climate chamber with evaluation pre§/during*/post§ of heart rate (HR)§* and blood pressure (BP)§*, spirometry§*, PNIF§, FeNO§, electrocardiogram (ECG)§*, body \& exhaled air temperature§*, capsaicin cough threshold test§, histamine bronchial challenge test§, and sampling of nasal fluid§, induced sputum§, and venous blood§. | Other | Asthmatic subjects, Healthy volunteers |
Primary outcome
Change in Forced Expiratory Volume in 1 seconds (FEV1)
Time frame: pre-, 5, 15, 25 and 35 minutes, 24 hours and 1 week post-exposure
Change in FEV1, calculated as a time-weighted average over the 35 minutes after the cold air exercise test and 24 hours and 1 week post-exposure. A maximal fall of 10% will be considered as positive response
14 secondary outcomes
Changes in asthma control
Time frame: Pre-exposure and immediately, 24 hours and 1 week post-exposure
Changes in respiratory symptom score
Time frame: Pre-exposure and immediately, 24 hours and 1 week post-exposure
Cough hypersensitivity
Time frame: Pre-exposure and 24 hours and 1 week post-exposure
Bronchial hyperreactivity
Time frame: Pre-exposure and 1 week post-exposure
Nasal hyperreactivity
Time frame: Pre-exposure and immediately and 24 hours post-exposure
Airway inflammation
Time frame: Pre-exposure and 24 hours and 1 week post-exposure
Cytokine pattern in the airways
Time frame: Pre-exposure and 24 hours and 1 week post-exposure
Biomarkers for airway inflammation
Time frame: Pre-exposure and 24 hours and 1 week post-exposure
Nasal inflammation
Time frame: Pre-exposure and immediately and 24 hours post-exposure
Systemic inflammation
Time frame: Pre-exposure and immediately, 24 hours and 1 week post-exposure
Biomarkers for systemic inflammation
Time frame: Pre-exposure and immediately, 24 hours and 1 week post-exposure
Changes in microbiome in lung and nose
Time frame: Pre-exposure and 1 week post-exposure
Evaluation of the heart rate pattern
Time frame: Pre-exposure and during the 90 minutes cold air exposure
Determining the exercise capacity
Time frame: Pre-exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lieven Dupont, Prof. dr principal investigator
KU Leuven/ UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold air exercise test in people with Asthma, Exercise-Induced, run by KU Leuven at 1 site in Belgium.
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 17 inclusion and 12 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: finished, as of the sponsor's last update on 17 Dec 2020. 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in 1 seconds (FEV1) (time frame: pre-, 5, 15, 25 and 35 minutes, 24 hours and 1 week post-exposure). 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 17 Dec 2020.