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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if wearing compression stockings during the day can reduce nighttime asthma symptoms. Researchers believe that fluid shifting to the upper body while lying down might worsen these symptoms. Compression stockings, which prevent fluid from pooling in the legs, may help alleviate this issue. The study seeks participants with asthma who frequently experience nighttime symptoms and are non-smokers or former smokers with a low history of smoking. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance asthma management.

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.

What prior data suggests that compression stockings are safe for asthma patients?

Research has shown that wearing compression stockings during the day is generally safe and comfortable. In one study, participants who wore these stockings for two weeks noticed less fluid in their legs. This reduction is important because it can help keep airways open, potentially improving sleep for people with asthma.

Another review of several studies found that light compression stockings effectively reduce leg swelling. This indicates that the stockings work well and are usually safe to use. Overall, compression stockings offer a non-invasive option with a good safety record, making them a potentially safe choice for managing symptoms related to fluid buildup. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Compression stockings are unique in asthma management because they offer a non-pharmacological approach that differs from standard treatments like inhalers, corticosteroids, or bronchodilators. While typical asthma treatments focus on opening airways or reducing inflammation, compression stockings might improve circulation and, potentially, respiratory function. Researchers are excited about this trial as it explores a novel method that could complement existing therapies, providing a simple, wearable option with potentially fewer side effects.

What evidence suggests that compression stockings might be an effective treatment for asthma?

Research has shown that wearing compression stockings during the day can help reduce leg swelling. This is important because, when lying down, fluid can move to the chest, potentially causing nighttime breathing problems for people with asthma. One study found that these stockings reduced leg fluid by about 192.6 ml in the evening, which is promising. In this trial, researchers will randomize participants in the asthma group to wear compression stockings or join a control group. Some asthma patients experienced less airway tightening at night when using compression stockings. While more research is needed, these early findings suggest that compression stockings could help relieve nighttime asthma symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Azadeh Yadollahi

Principal Investigator

Scientist

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38365985/

A pilot study to assess the effects of preventing fluid ... This study investigates whether reducing leg fluid volume by wearing compression stockings during the day would attenuate small airway narrowing in patients ...

2. researchgate.net researchgate.net/publication/344001079_Managing_adult_asthma_The_2019_GINA_guidelines

Managing adult asthma: The 2019 GINA guidelines Results After 2 weeks of wearing compression stockings, the LFV measured in the evening was reduced (∆ = − 192.6 ± 248.3 ml, p = 0.02) ...

3. jvsvenous.org jvsvenous.org/article/S2213-333X(24)00361-5/fulltext

Results from a comparative study to evaluate the treatment ... The NPCD was more effective than an APCD and resulted in superior limb volume decrease, greater improved quality of life, adherence, mobility, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11764854/

Results from a comparative study to evaluate the treatment ... Key Findings: Data from 71 patients (108 affected limbs) with lower extremity lymphedema demonstrated significant greater improvements in limb edema and in ...

5. pharmacytimes.com pharmacytimes.com/view/study-leg-compression-therapy-helps-improve-heart-failure-symptoms

Study: Leg Compression Therapy Helps Improve Heart ... The findings indicate significant improvements in heart failure symptoms, including reduced edema and decreased brain natriuretic peptide levels ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4081237/

Graduated compression stockings - PMC A meta-analysis of 11 RCTs reported that compression of 15–20 mm Hg showed beneficial effects on edema and symptoms, as compared with compression of less than ...

7. researchgate.net researchgate.net/publication/8606024_Compression_Stockings_Reduce_Occupational_Leg_Swelling

Compression Stockings Reduce Occupational Leg Swelling Evening edema was significantly reduced to 40.3 mL by light support stockings, to -34.1 mL by compression class A, to -39.6 by compression class ...

8. aaaai.org aaaai.org/Aaaai/media/Media-Library-PDFs/Allergist%20Resources/Statements%20and%20Practice%20Parameters/WGR-AAAAI-Asthma,-Cough,-Diagnosis-and-Treatment-Committee.pdf

Ensuring equitable access to guideline-based asthma care ... How do we define mild asthma and treat it to minimize risk? How do we consistently report asthma-related trial data to influence guidelines in a stan- dardized ...