Compression Stockings for Asthma
Recruiting in Palo Alto (17 mi)
Overseen byAzadeh Yadollahi
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Disqualifiers: Uncontrolled hypertension
No Placebo Group
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.
12345Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Healthy groupActive Control2 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 groupActive Control2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toronto Rehabilitation Institute (TRI)Toronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Chapter 14: Acute severe asthma (status asthmaticus). [2018]Acute severe asthma, formerly known as status asthmaticus, is defined as severe asthma unresponsive to repeated courses of beta-agonist therapy such as inhaled albuterol, levalbuterol, or subcutaneous epinephrine. It is a medical emergency that requires immediate recognition and treatment. Oral or parenteral corticosteroids should be administered to all patients with acute severe asthma as early as possible because clinical benefits may not occur for a minimum of 6-12 hours. Approximately 50% of episodes are attributable to upper respiratory infections, and other causes include medical nonadherence, nonsteroidal anti-inflammatory exposure in aspirin-allergic patients, allergen exposure (especially pets) in severely atopic individuals, irritant inhalation (smoke, paint, etc.), exercise, and insufficient use of inhaled or oral corticosteroids. The patient history should be focused on acute severe asthma including current use of oral or inhaled corticosteroids, number of hospitalizations, emergency room visits, intensive-care unit admissions and intubations, the frequency of albuterol use, the presence of nighttime symptoms, exercise intolerance, current medications or illicit drug use, exposure to allergens, and other significant medical conditions. Severe airflow obstruction may be predicted by accessory muscle use, pulsus paradoxus, refusal to recline below 30°, a pulse >120 beats/min, and decreased breath sounds. Physicians' subjective assessments of airway obstruction are often inaccurate. More objective measures of airway obstruction via peak flow (or forced expiratory volume in 1 second) and pulse oximetry before oxygen administration usually are helpful. Pulse oximetry values >90% are less commonly associated with problems although CO(2) retention and a low Pao(2) may be missed.
Allergies, mediators and asthma. [2021]Asthma is a term that has been used for centuries to describe states of breathlessness associated with wheezing. However, there are well-known difficulties in defining asthma, as it encompasses such a broad clinical spectrum ranging from mild, rapidly reversible, bronchospasm to severe, intractable, chronic airflow obstruction. Moreover, reversibility of airflow obstruction, a cardinal feature used to identify asthma, may be demonstrated only with difficulty in certain cases, such as severe, acute asthma attacks, which necessitate several days of treatment before any reversibility can be achieved.
Physiologic diagnosis and function in asthma. [2004]Asthma is a condition in which there is airway hyperresponsiveness, with the propensity for widespread, reversible airways narrowing on exposure to diverse inciting factors (triggers). Inhalation of nonspecific agents such as methacholine or histamine leads to bronchoconstriction in most cases, and in some, the bronchoconstriction follows exposure to specific agents such as antigen or occupational irritants. Chest tightness and cough, which are the most common symptoms of asthma, are probably the result of inflammation mucus plugs, edema, or smooth muscle constriction in the small peripheral airways. Because major obstruction of the peripheral airways can occur without recognizable increases of airway resistance or FEV1, the physiologic alterations in acute exacerbations are generally subtle in the early stages. Poorly ventilated alveoli subtending obstructed bronchioles continue to be perfused, and as a consequence, the P(A-a)O2 increases and the PaO2 decreases. At this stage, ventilation is generally increased, with excessive elimination of carbon dioxide and respiratory alkalemia. In the more severe exacerbation, lung volume is increased and the static volume-pressure curve is shifted up (lung volume is greater) and to the left (pressure is lower) while the shape of the curve is unaltered. The airway obstruction is reversible and there is generally improvement in air flow rates following administration of beta-agonists and anti-inflammatory agents. The changes in mechanical properties are also reversible, and therapeutic intervention usually results in a shift of the PV curve downward toward the normal position, for example, a decrease in TLC and an increase in the elastic recoil pressure at any particular lung volume. Failure to take these changes into account may underestimate the impact of therapy. The PaO2 decreases (and the P(A-a)O2 increases) as the work of breathing increases, and when it becomes excessive (and/or the FEV1 falls below 20% to 25%), the PaCO2 begins to increase. Therefore, in any patient with asthma, a decreasing PaO2 and an increasing PaCO2, even into the normal range, indicates severe airway obstruction that is leading to respiratory muscle fatigue and patient exhaustion.
Pharmacotherapeutic strategies for critical asthma syndrome: a look at the state of the art. [2022]'Critical Asthma Syndrome' (CAS) is an umbrella term proposed to include several forms of asthma, responsible for acute and life-threatening exacerbations. CAS requires urgent and adequate supportive and pharmacological treatments to prevent serious outcomes.
Asthma pharmacotherapy. [2013]Asthma is a chronic inflammatory disease of the airway that leads to airway obstruction via bronchoconstriction, edema, and mucus hypersecretion. The National Asthma Education and Prevention Program has outlined evidence-based guidelines to standardize asthma therapy and improve outcomes. The initial recommendation of choice for persistent asthmatic patients is an inhaled corticosteroid (ICS). Long-acting beta-2 agonists in combination with ICS, oral corticosteroids, leukotriene modifiers, and anti-IgE therapeutic options can be considered for patients with persistent or worsening symptoms. Many novel therapies are being developed, with an emphasis on anti-inflammatory mechanisms, gene expression, and cytokine modification.