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Asthma clinical trials

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NCT ID: NCT06174207 Not yet recruiting - Asthma Clinical Trials

Hyperoxia During Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Chronic respiratory diseases are a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. The effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation. Aim: The goal of this study is to analyse the effect of supplemental oxygen given during a constant work rate exercise test (CWRET) on a cycle ergometer compared to sham air. Methods: We plan to include 25 Patients respiratory patients undergoing pulmonary rehabilitation (male and female; aged >18 years; stable condition >3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88%) with exercise induced hypoxemia defined by a fall in oxygen saturation by ≥ 4% during a 6-minute walking test. Patients will undergo an incremental exercise test with a ramp protocol (for evaluating the maximal workload) and two CWRET (75% of the maximal workload) with ambulatory oxygen or placebo (sham air) via standard nasal canula at a flow rate of 5l/min. Patients and assessors will be blinded. The difference endurance time of the CWRET with oxygen vs. sham air will be the primary outcome of this study. Data will be summarized by means (SD) and medians (quartiles) for normal and non-normal distributions. Effects of treatment will be evaluated by mean differences with 95% confidence intervals, T-tests or Wilcoxon matched pair tests as appropriate. A p-value threshold of <0.05 or a confidence interval not including zero will be considered as statistically significant. Analyses will be performed according to the intention to treat principle.

NCT ID: NCT06163807 Not yet recruiting - Chronic Asthma Clinical Trials

Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry

MEGA
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

Primary objective - To study the stability of different phenotypes and endotypes of asthma at 3, 5, and 7 years of follow-up and - in MEGA COHORT and in patients on biologic treatment Secondary objective(s) - To study biomarkers variation post-treatment in patients with and without Nasal Polyposis - To demonstrate the existence of different subtypes of eosinophils that may be phenotypically and functionally heterogeneous - To increase the number of patients in the cohort on biologic treatment to reach at least 900 (400 over the current cohort).

NCT ID: NCT06159127 Not yet recruiting - Asthma Clinical Trials

SMART@Home Feasibility Trial

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools. Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.

NCT ID: NCT06154304 Not yet recruiting - Bronchial Asthma Clinical Trials

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

NCT ID: NCT06150300 Not yet recruiting - Asthma Clinical Trials

Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population.

STAPLE
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This is a randomized control trial evaluating the effect of a novel mobile application-delivered pulmonary rehabilitation program in adult severe asthma patients. The intervention will include eight weeks of exercise videos that progress in difficulty, as well as asthma-specific educational content. The primary outcome measure is change in functional exercise capacity as measured by six-minute walk distance. Secondary outcome measures will include evaluation of overall feasibility, and change in CPET parameters such as VO2max. Change in asthma control questionnaire (ACQ), asthma quality of life questionnaire (AQLQ) and PRAISE self-efficacy score will also be evaluated.

NCT ID: NCT06147453 Not yet recruiting - Asthma Clinical Trials

Effect of OPEP on Mucus Plugging and Airflow Obstruction in Patients With Moderate-to-severe Asthma

AeroMUC
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to evaluate the effect of daily AerobikaTM Oscillating Positive Expiratory Pressure (OPEP) device use on mucus plugging and airway function in adult patients with moderate-to-severe asthma.

NCT ID: NCT06141616 Not yet recruiting - Physical Inactivity Clinical Trials

Effects of Pulmonary Rehabilitation on Clinical Outcomes in Children With Asthma

Start date: December 2023
Phase: N/A
Study type: Interventional

Although the practice of physical activity is recommended for children with asthma, the scientific literature available so far has focused mainly on improving functional capacity and quality of life. However, the effects of pulmonary rehabilitation in this population, especially in improving the level of physical activity in daily living (PADL) and activities of daily living (ADLs) have not yet been investigated in depth. Therefore, the objective of this study is to verify the effects of pulmonary rehabilitation on PADL, ADL, and other clinical outcomes of children with asthma. For this, a randomized clinical trial will be carried out that will have 2 groups: the control group (CG), which will receive only educational sessions, and the intervention group (IG) which will participate in a pulmonary rehabilitation program with supervised aerobic training performed three times a week with sessions of 60 minutes each. The total duration of interventions in both groups will be 12 weeks. The primary outcomes of this study are PADL (assessed using a physical activity monitor - Actigraph) and ADL; however, the following will also be evaluated: lung function, functional capacity, asthma control, and quality of life. We hypothesized that the performance of regular physical activity and supervised physical exercise by individuals with asthma could positively impact health outcomes with better control of asthma symptoms, better performance in ADL and PADL, and better quality of life.

NCT ID: NCT06116292 Not yet recruiting - Asthma Clinical Trials

Impact of the Implementation of a Telemedicine Program on Patients Diagnosed With Asthma

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Introduction: Asthma is one of the most common chronic respiratory diseases worldwide. Despite the extensive knowledge of the condition and available therapeutic options, severe asthmatic patients have poor disease control in 50% of cases. Objective: To assess the impact of implementing a mobile application (ESTOI) in patients diagnosed with asthma on disease control, treatment adherence, and perceived quality of life. Methodology: A 52-week randomized clinical trial involving asthma patients receiving care at a highly specialized hospital in Spain. A total of 108 patients will be included and divided into two groups. The intervention group will receive more comprehensive monitoring than usual, including access to the ESTOI application. The Asthma Control Test (ACT) questionnaire will be used as the primary assessment variable. Other variables to be studied include the Inhaler Adherence Test (TAI), the number of exacerbations, peak expiratory flow, exhaled nitric oxide examination, hospital anxiety and depression scale, asthma quality of life questionnaire, forced spirometry parameters (FVC, FEV1, and reversibility), and analytical parameters (eosinophilia and IgE).

NCT ID: NCT06112405 Not yet recruiting - Asthma Clinical Trials

Real World App-based CCAAP Management of Children With Asthma

Start date: November 25, 2023
Phase: N/A
Study type: Interventional

This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to compare the App-based efficacy of China Children Asthma Action Plan (CCAAP) and written CCAAP used in management of children with asthma. The main questions are:1. Is the App-based CCAAP effective/feasible in management of children with asthma? 2. Is the App-based CCAAP better than written CCAAP in management of children with asthma?

NCT ID: NCT06105710 Not yet recruiting - Asthma Clinical Trials

Mechanistic Insights From Bronchoscopy Airway Samples

MIBAS
Start date: January 2024
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to examine the mechanisms of asthma. The investigators are comparing the cells of individuals with and without asthma and looking at the roles various parts of the cell play in the production and secretion of mucus.