Clinical Research Directory

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

The aim of this study is to evaluate usual care versus biomarker-directed care (using blood eosinophil counts) for the management of asthma patients in primary care setting. The study hypothesizes that BEC is a valuable biomarker that can guide asthma treatment, and result in reduction in asthma exacerbations, better symptom control and improvement in quality of life compared to usual arm in mild to moderate asthma patients in the primary care setting. Researchers would compare using blood eosinophil count guided to usual care to see if biomarker-directed asthma treatment and management

Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation

This study is testing a new way to help adults with asthma get follow up care after an emergency room (ER) visit for an asthma attack. Many people who come to the ER for asthma never see an asthma specialist afterward, even though specialists can offer treatments such as advanced inhalers or biologic medicines that may prevent future attacks. The study will compare two approaches. One group will receive a telehealth appointment with an asthma specialist that is scheduled for them before they leave the ER. The other group will receive the usual care, which typically includes a standard referral but no scheduled appointment. All participants will be offered a prescription for standard controller medication at discharge. The main question the study aims to answer is whether arranging a telehealth visit directly from the ER increases the number of patients who complete a follow up appointment with an asthma specialist within three months. The study will also look at whether this approach improves asthma control, reduces repeat ER visits, and helps patients better understand and use their asthma medications. This research may help identify a practical way to improve access to asthma specialists and reduce the burden of asthma for patients who frequently rely on emergency care.

Bronchial Thermoplasty for Adults With Severe Asthma in the Biologic Era

Rationale: For patients with severe asthma that remain uncontrolled with exacerbations despite biologics or patients who are not eligible for biologics, there is no reimbursed treatment other than pulmonary rehabilitation in the Netherlands. Pulmonary rehabilitation is known to have a limited effect for a limited amount of time. Bronchial thermoplasty or bronchial ablation (BT) is a non-pharmacological treatment for asthma aiming to restore abnormal airway function by using an endobronchial approach. Previous RCT's reported efficacy on exacerbations and asthma related quality of life (AQLQ), but were performed before large availability of biologic treatments. Although a single BT treatment is not without costs, these costs seem to outweigh the costs that can be saved by the long-term (\>5 years) lowering effect of BT on the frequency of exacerbations and hospitalizations and omitting long term use of trials and switches of biologics. Therefore, the investigators hypothesize that BT, in the era of biologics, is superior (in terms of exacerbations and quality of life) over standard care and cost-effective in patients whose asthma remains uncontrolled despite optimal anti-inflammatory treatments including biologics, and the investigators propose to test this hypothesis in a RCT. Objective: To investigate the impact of BT as compared to standard of care in severe asthma patients that remain uncontrolled despite standard treatment including adequate doses of inhaled preventer therapies with or without biologics on: 1. rate of exacerbations 2. asthma related quality of life (AQLQ) 3. 1-year and 5-year cost-effectiveness and cost utility Study design: Investigator-initiated randomized, multicenter, parallel-group interventional RCT of severe asthma patients undergoing either BT (active arm) or standard care (control arm). Study population: Adult, uncontrolled severe asthma patients despite optimal medical therapy including one or more trials of treatment with a biologic or ineligible for biologic treatment AND 2 or more severe asthma exacerbations in the previous year AND FEV1 ≥ 50% predicted. Intervention: BT (active arm) versus standard care (control arm). Main study parameters/endpoints: The primary endpoint of this study is the between group difference in severe exacerbation rate after 12 months of follow-up. The main secondary endpoints are between group differences after 12 months of follow-up and within group differences before and after intervention or standard care. Parameters that will be explored are: AQLQ (minimal clinically important difference \>0.5), ACQ (minimal clinically important difference \>0.5), exacerbation rate (before and after BT) and hospitalizations (rate and % subjects).

Individualizing Treatment for Asthma in Primary Care (Full Study)

While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects. This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.

Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations

The goal of this clinical trial is to learn if nebulized ketamine helps treat moderate to severe asthma attacks in adults in the emergency department. It will also learn about the safety of ketamine when inhaled through a nebulizer. The main questions it aims to answer are: * Does nebulized ketamine improve breathing more than standard treatment alone? * What side effects, if any, do participants experience after receiving nebulized ketamine? Researchers will compare nebulized ketamine to a placebo (a saltwater mist with no medication) to see how well it works and how safe it is. Participants will: * Receive either nebulized ketamine or a placebo mist, along with standard asthma treatment * Have their breathing checked before and after treatment using a peak flow meter * Be monitored for 60 minutes and have their symptoms, vital signs, and any side effects recorded

DOSE Trial: Optimal Dose of Oral Corticosteroids to Treat Asthma Exacerbations

Patients with severe asthma frequently experience exacerbations of their disease. The heterogeneity of asthma exacerbations represents a major challenge for patients and healthcare providers, making treatment difficult. Current guidelines recommend varying doses of short-term oral corticosteroids (OCS) as first-line treatment for asthma exacerbations. However, studies supporting the optimal dose of OCS to treat asthma exacerbations are rare. This study aims to evaluate the feasibility, acceptability, and safety of a randomized clinical trial with different OCS regimens for patients and physicians. Additionally, evaluate the success rate of different OCS dosages to support power calculations for a non-inferiority trial. In this pilot, parallel, randomized, controlled study, patients with severe asthma exacerbation, considered to require treatment with OCS according to physician judgment after a complete evaluation will be randomized to 1) 3 days of 50 mg prednisone followed by 7 days of placebo, 2) 3 days of 50 mg prednisone and 4 days of 25 mg prednisone followed by 3 days of placebo, or 3) 5 days of 50 mg prednisone and 5 days of 25 mg prednisone. Randomized patients will be assessed for daily symptoms and overall perception of well-being, in addition to asthma control, quality of life as well as additional medical visits. Lung function and inflammation will also be measured. Feasibility and acceptability will be defined by a participation rate \>80%, while safety will be defined as an increase in OCS doses in \<20% of patients in one arm or an emergency room visit in \<10% of patients in one arm. Success will be defined as no increased or prolonged doses of OCS, no re-consultation for OCS or escalation to antibiotics, reduction of symptoms, and return of lung function to \>80% of its optimal level. In addition to determining the feasibility and safety of different OCS regimens to treat asthma exacerbations, this trial will help us determine the optimal design for a randomized clinical trial using different OCS regimens. The exacerbation clinic is already operational with 4 to 5 patients/week assessed and treated. We have all the resources on site to carry out this project.

Study on Effect of Papworth Technique in Anemic Asthmatic Pediatrics

As asthma is chronic condition which interferes with quality of life and exercise tolerance, so it is important to find out cost-effective alternative for the management of asthma due to increased prevalence and rising health care cost as well . Therefore, to provide comprehensive asthma treatment, it is necessary to rule out and address the factor affecting quality of life and exercise tolerance. Asthmatics require stepwise approach which contains assessment treatment planning and review of response. Along with this modification of risk factors, controller therapy is adjusted accordingly. But this is inadequate for asthma management as pharmacological management has some side effects. So, in addition to medical care, Papworth method provides good adjuvant to control asthma symptoms. Asthma subjects require comprehensive approach to deal with these hyperinflation and hyperventilation which are common manifestations of asthma

A Cohort Study of Risk Factors and Prognosis for Frequent Acute Asthma Exacerbations Phenotype

Acute asthma exacerbations are an important public health problem and a major cause of disease progression and healthcare burden for people with asthma. Frequent acute exacerbations are likely to be a distinct asthma phenotype. Further research is needed to identify risk factors for frequent acute exacerbations, but previous studies have mostly been cross-sectional studies at a single time point or prospective studies based on smaller sample sizes. Moreover, most of the studies on frequent acute exacerbations have been conducted in severe or refractory asthma, whereas a certain proportion of non-severe asthmatics may also experience frequent acute exacerbations, the risk factors of which remain to be further evaluated. The main objectives of this project are to compare the baseline clinical, inflammatory, pathophysiological, comorbidities, environmental pollutants and meteorological exposure characteristics of patients with frequent acute exacerbations and those with non-frequent acute exacerbations irrespective of asthma severity, and to develop a disease prediction model for frequent acute exacerbations; and to develop a cohort of patients with frequent acute exacerbations of asthma, observe their prognosis and response to treatment, and search for prognostic factors associated with them. The successful implementation of this study will help in the early identification of patients with frequent acute exacerbations, clarify the factors associated with poor prognosis in this group of patients, and thus provide an individualized plan for the treatment and prevention of this type of patients, which is of great significance in achieving good asthma control, reducing the burden of disease, decreasing the cost of healthcare, and saving clinical healthcare resources and costs.