NCT03747211: ATOM

Asthma Severity in Women: The Influence of Training and Menopause

Terminated NA Last updated 23 June 2021

What this trial tests

NA trial testing Aerobic exercise in Late-Onset Asthma in 12 participants. Terminated before completion.

Timeline

12 February 2019

Primary endpoint
1 May 2021

1 May 2021

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	12 February 2019
Primary completion	1 May 2021
Estimated completion	1 May 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Aerobic exercise — full drug profile →

Conditions studied

• Late-Onset Asthma — all drugs for Late-Onset Asthma →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 45 to 75, female only, with Late-Onset Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Late-onset asthma in women is characterized by poor disease control and reduced quality of life despite intensive treatment with inhaled steroid and beta2-agonist. The condition is further worsened at menopause due to the loss of estrogen leading to increased asthma exacerbation frequency, increased airway inflammation and decreased lung function. Exercise training may increase disease control of asthma patients, but to what extent the same effect is seen in postmenopausal women with late-onset asthma is unknown. These asthma patients represent a phenotype that is characterized by low eosinophilic airway inflammation, severe symptoms, moderate obesity and poor response to conventional medicine. Thus, our hypothesis is that regular physical exercise is especially associated with an improvement in asthma control in this phenotype. The aim of this project is to test this hypothesis and to assess whether an improvement is associated with reduced local and systemic inflammation, change in heart function, lung function and/or body composition.

Study design: 40 postmenopausal women with late-onset asthma are recruited via the outpatient clinic at the Respiratory Department at Bispebjerg Hospital and through advertisement. The participants are randomized 1:1 into two groups. One group performs supervised exercise training (spinning) three times per week for 12 weeks while the other group is a control group. Before and after the intervention asthma control, local and systemic inflammation, heart function and body composition is measured.

Results: Analysis will be performed to detect changes within and between the groups before and after intervention. Primary outcome is change in ACQ (Asthma Control Questionnaire). Local and systemic inflammation is measured by changes in bronchial challenge to methacholine, sputum cell count and blood tests. Furthermore, secondary outcomes include change in heart function measured by stress-echocardiography and change in body composition measured by Dual-energy X-ray absorptiometry (DEXA).

Conclusion: There are to date no prospective studies that can support recommendations containing asthma rehabilitation with supervised regular physical activity for postmenopausal women. Thus, this study will provide novel understanding of the importance of physical activity in a chronic disease such as asthma.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effect of aerobic exercise training on asthma control in postmenopausal women (ATOM): a randomized controlled pilot study.
   Hansen ESH, Rasmusen HK, Hostrup M, Hellsten Y, et al · · 2023 · cited 2× · PMID 37674777 · DOI 10.1080/20018525.2023.2251256
2. Effect of aerobic exercise training on asthma control in postmenopausal women (the ATOM-study): protocol for an outcome assessor, randomised controlled trial.
   Hansen ESH, Hostrup M, Rasmusen HK, Hellsten Y, et al · · 2021 · cited 2× · PMID 33888532 · DOI 10.1136/bmjopen-2021-049477