The Effect of Physical Exercise in a Cold Air Environment on Normal Volunteers and Asthmatic Patients

NCT03840044 | Completed

• 1 other identifier: s61661
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asthma, Exercise-Induced

Keywords

Asthma; Exercise; Cold air exposure

Outcome Measures

Primary Outcomes (1)

• 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

  pre-, 5, 15, 25 and 35 minutes, 24 hours and 1 week post-exposure

Secondary Outcomes (14)

• Changes in asthma control

  Pre-exposure and immediately, 24 hours and 1 week post-exposure

• Changes in respiratory symptom score

  Pre-exposure and immediately, 24 hours and 1 week post-exposure

• Cough hypersensitivity

  Pre-exposure and 24 hours and 1 week post-exposure

• Bronchial hyperreactivity

  Pre-exposure and 1 week post-exposure

• Nasal hyperreactivity

  Pre-exposure and immediately and 24 hours post-exposure

Study Arms (2)

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.

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.

Other: Cold air exercise test

Interventions

Cold air exercise test OTHER

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§.

Asthmatic subjects; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced; Asthma; Motor Activity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases; Behavior

Study Officials

• Lieven Dupont, Prof. dr

  KU Leuven/ UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: Healthy volunteers will be compared with asthmatic subjects

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 15, 2019
• Study Start: June 3, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)