Compression Stockings for Asthma

Overseen By Cristina O Francisco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Uncontrolled hypertension

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Nocturnal worsening of asthma is common. It is characterized by overnight exacerbation of asthma symptoms such as shortness of breath, chest tightness, coughing, and wheezing, increased need of asthma medications and airway hyperresponsiveness, and decline in lung function (1). Nocturnal asthma has been attributed in part to circadian variations in lung function and airway inflammation. However, other factors including sleep, supine posture and lung volume may also contribute to nocturnal asthma. Current treatments often improve nighttime asthma symptoms. Nevertheless, nocturnal asthma is still common. Up to 2/3rd of asthma patients report nocturnal asthma symptoms, and many asthma related events occur at night, indicating poor asthma control. Results from an ongoing study suggest that in asthma while subjects were supine, fluid shifted out of the legs and accumulated in the thorax (rostral fluid shift) contributing to lower airway narrowing in asthma. A previou study has shown that wearing compression stockings during the day reduces fluid retention in the legs, reduces nocturnal rostral fluid shift out of the legs, and improves sleep apnea (2, 3). The aims of the proposed study is investigate whether off-the-shelf, below the knee compression stockings will attenuate nocturnal fluid shift and lower airway narrowing in asthma.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How do compression stockings differ from other asthma treatments?

Compression stockings are unique for asthma treatment as they are typically used to improve blood circulation in the legs, unlike standard asthma treatments like inhaled corticosteroids or beta-agonists, which target airway inflammation and bronchoconstriction directly. ^{1 2 3 4 5}

Research Team

Azadeh Yadollahi

Principal Investigator

Scientist

Eligibility Criteria

This trial is for non-smokers or former smokers with less than 10 pack-years of smoking history who suffer from asthma, specifically those experiencing worsening symptoms at night. It aims to explore if wearing compression stockings can help reduce their nocturnal asthma issues.

Inclusion Criteria

I have never smoked or smoked less than 10 packs a year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to wear compression stockings or to control group for two weeks, with a crossover at the end of the period

2 weeks

1 visit (in-person), 1 phone call

Follow-up

Participants are monitored for changes in fluid volumes, respiratory impedance, pulmonary diffusion capacity, and lung volume after the intervention

2 weeks

Treatment Details

Interventions

• Compression Stockings

Trial Overview The study is testing the effectiveness of below-the-knee compression stockings in reducing nighttime fluid shift and airway narrowing in asthmatic patients, compared to a control group not using these stockings.

Participant Groups

Group I: Healthy group Active Control 2 Interventions

Participants will be randomized to wear compression stockings or to control group for two weeks and cross over in the end of the period. When assigned to wear compression stockings, they will be instructed to put the stockings on as soon as they get up in the morning and to remove them just prior to bedtime for two weeks. If they have become loose, a new pair will be fitted. They will be given a diary to record the time they put on and remove the compression stockings each day. They will be telephoned after one week to check the fit of the compression stockings.

Group II: Asthma group Active Control 2 Interventions

Participants will be randomized to wear compression stockings or to control group for two weeks and cross over in the end of the period. When assigned to wear compression stockings, they will be instructed to put the stockings on as soon as they get up in the morning and to remove them just prior to bedtime for two weeks. If they have become loose, a new pair will be fitted. They will be given a diary to record the time they put on and remove the compression stockings each day. They will be telephoned after one week to check the fit of the compression stockings.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

Immediate treatment with oral or parenteral corticosteroids is crucial for patients experiencing acute severe asthma, as benefits may take 6-12 hours to manifest, highlighting the importance of early intervention.

About 50% of acute severe asthma episodes are linked to upper respiratory infections, with other triggers including nonadherence to medication, allergen exposure, and irritant inhalation, emphasizing the need for thorough patient history and assessment of potential causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chapter 14: Acute severe asthma (status asthmaticus). Shah, R., Saltoun, CA.[2018]

Asthma is a complex condition characterized by varying degrees of breathlessness and wheezing, making it challenging to define due to its broad clinical spectrum.

The reversibility of airflow obstruction, a key feature for diagnosing asthma, can be difficult to demonstrate, especially in severe cases where significant treatment time is required before improvement is observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergies, mediators and asthma. Bryant, DH.[2021]

Asthma causes airway hyperresponsiveness and bronchoconstriction, leading to symptoms like chest tightness and cough due to inflammation and smooth muscle constriction, which can occur even without significant changes in airway resistance.

Therapeutic interventions, such as beta-agonists and anti-inflammatory agents, can effectively reverse airway obstruction and improve airflow, but it's crucial to monitor changes in oxygen levels (PaO2) and carbon dioxide levels (PaCO2) to assess the severity of the condition and the effectiveness of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic diagnosis and function in asthma. Cherniack, RM.[2004]

Inhaled beta2-agonists are the primary treatment for Critical Asthma Syndrome (CAS), and their effectiveness is enhanced when combined with inhaled anticholinergic agents and systemic corticosteroids to reduce airway inflammation.

Timely recognition and aggressive treatment are crucial for managing CAS, but prevention strategies need further development to minimize acute exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic strategies for critical asthma syndrome: a look at the state of the art. Vatrella, A., Maglio, A., Pelaia, C., et al.[2022]

Inhaled corticosteroids (ICS) are the first-line treatment recommended for patients with persistent asthma, as they help reduce inflammation and improve airway function.

New therapies are being developed that focus on anti-inflammatory mechanisms and modifying gene expression and cytokines, which could offer additional options for managing asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma pharmacotherapy. Schofield, ML.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Chapter 14: Acute severe asthma (status asthmaticus). [2018]

2. Australia pubmed.ncbi.nlm.nih.gov

Allergies, mediators and asthma. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Physiologic diagnosis and function in asthma. [2004]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic strategies for critical asthma syndrome: a look at the state of the art. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Asthma pharmacotherapy. [2013]