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Respiration Disorders clinical trials

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NCT ID: NCT05077969 Terminated - COVID-19 Clinical Trials

Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)

Start date: December 29, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.

NCT ID: NCT04655508 Terminated - Respiratory Disease Clinical Trials

Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation

RESPPEDOBS
Start date: May 21, 2021
Phase: Phase 3
Study type: Interventional

Bronchiolitis Obliterative Syndrome (BOS) is the primary noninfectious pulmonary complication after hematopoietic stem cell transplantation (HSCT) and usually carries a poor prognosis. It occurs in about 10% of children underwent HSCT. The National Institutes of Health (NIH) published guidelines and criteria for the diagnosis of BOS. BOS defined by spirometric criteria according to modified NIH consensus guidelines: FEV1 < 75% predicted and a greater than 10% decline from pretransplant baseline, and FEV1/FVC <0.7 (FCV: Forced Vital Capacity). Nevertheless Cheng and al. indicate that the magnitude of FEV1 decline before diagnosis exceeded the diagnostic requirement of a greater than 10% decline compared with baseline FEV. Moreover, the decline in FEV1 prior to BOS diagnosis appeared to occur within 6 months for those patients. Recent studies suggest that any intervention should be targeted during the FEV1 decline, and before the diagnosis of BOS. For this, inhalated treatment are used: Bergeron et al. reported improvements in symptoms as well in FEV1 one month followed treatment including formoterol and budesonide in a prospective trial including adults (12% increase of FEV1 for 62% adults). Williams and al. in another prospective adult's cohort, showed that the association between fluticasone, montelukast and azythromycin was associated with stable lung function, reduced systemic corticosteroids, and improved quality of life at 3 months for adults with BOS. In our national French prospective cohort which include 300 children with HSCT from 2014 to 2017 (RESPPEDHEM Programme Hospitalier de Recherche Clinique 2012), 35% of children presented a decline of FEV1≥ 10% without BOS criteria (FEV1 < 75% and FEV1/FVC <0.7). Among them, some received combination of corticoids and long acting beta agonists for 6 months. Children with this type of inhalated treatment improved their FEV1 to 88.1% predicted while children without any treatment have a FEV1 at 80.7% predicted. Our hypothesis is that association of Fluticasone Propionate and Salmeterol can be used as a treatment of the decline of FEV1 for children and so prevent BOS.

NCT ID: NCT04652518 Terminated - Covid19 Clinical Trials

LYT-100 in Post-acute COVID-19 Respiratory Disease

Start date: December 11, 2020
Phase: Phase 2
Study type: Interventional

This study is being conducted in two parts, A and B. Part A is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications. Part B is an Open Label Extension (OLE) study for patients who complete Part A.

NCT ID: NCT04603963 Terminated - Covid19 Clinical Trials

Inspiratory Muscle Training in Patients With COVID-19

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

COVID 19 has become a pandemic and has led to high demand on healthcare systems. It can cause a severe acute respiratory syndrome (SARS CoV-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. Elderly, obese and people with chronic diseases are more susceptible to contracting the disease, this profile of patients already has a predisposition for respiratory muscle weakness and in this context, after clinical stability, it is still necessary in a hospital environment to approach respiratory and motor physiotherapy. to optimize the recovery of these patients. Objective: Improved breathing, functionality, exercise capacity and muscle strength in non-critical patients. Method: Prospective randomized clinical study where one group received motor and respiratory physiotherapy and the other group performed the same therapy associated with inspiratory muscle training. Results: The findings will be compared before and after the approach and will be presented in graphs and tables. Statistical tests will be used considering a significance level of 5%.

NCT ID: NCT04599101 Terminated - Bronchiolitis Clinical Trials

Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe

Start date: November 21, 2020
Phase: N/A
Study type: Interventional

This research study will evaluate the difference in effectiveness of nasal suction between two different suction devices (NoseFrida and bulb syringe) in infants that have bronchiolitis. Bronchiolitis (a virus infection that goes into the lungs, which subsequently causes difficulty breathing, difficulty sleeping, and difficulty eating and drinking in children) is a common infection in young children. The caregiver-participants will be supplied with a suction devices (either NoseFrida and bulb syringe suction). The device should be used to clear nasal secretions as needed following discharge from the Emergency Center. The participants will be asked to use either a NoseFrida device or a bulb syringe. Caregivers will monitor how well their baby is breathing, eating/drinking, sleeping and how many times the baby has been seen by a medical provider in the 5 days post discharge from the Emergency Center. Post discharge, caregivers will complete a REDCAP survey asking questions about how their baby has been doing over the first 5 days following hospital discharge. REDCAP survey will be sent day 5 and again on day 7 if not completed. This completes study involvement.

NCT ID: NCT04477993 Terminated - SARS-CoV2 Clinical Trials

Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19

RUXO-COVID
Start date: August 14, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.

NCT ID: NCT04397692 Terminated - COVID-19 Clinical Trials

Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

Start date: June 13, 2020
Phase: N/A
Study type: Interventional

The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

NCT ID: NCT04331054 Terminated - Covid-19 Infection Clinical Trials

Protective Role of Inhaled Steroids for Covid-19 Infection

INHASCO
Start date: April 13, 2020
Phase: Phase 3
Study type: Interventional

We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.

NCT ID: NCT04086953 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Validation of a Walk-Time Limit Test (WTLT) Derived From the 6-Minute Walk Test (6-MWT) in Patients With Chronic Cardiovascular or Respiratory Diseases

TTLM
Start date: February 20, 2020
Phase: N/A
Study type: Interventional

Many exercise tests are commonly used to evaluate the changes of exercise tolerance following rehabilitation programs in patients with chronic respiratory diseases. Among the tests (6-MWT, incremental test, ...), the literature seems to indicate that endurance time is the most responsive parameter for detecting and quantifying changes in exercise capacity following a rehabilitation program. Although its clinical interest is undeniable, the endurance shuttle walking test is rarely used because it requires the prior performance of two incremental shuttle walking tests to determine the walking speed imposed on the patient. In this protocol, we propose to test a Walk-Time Limit Test (WTLT) derived from the 6-minute walk test (6-MWT) and based on the average walking speed achieved in this test commonly used in the follow-up of patients with chronic diseases. TTLM validation would improve the functional assessment of patients with chronic diseases while limiting the number of exercise tests.

NCT ID: NCT03745196 Terminated - Asthma Clinical Trials

The Effect of PC945 on Aspergillus or Candida Lung Infections in Patients With Asthma or Chronic Respiratory Diseases

Start date: November 15, 2018
Phase: Phase 2
Study type: Interventional

This study tests the effects of an experimental drug PC945 in people with asthma or other chronic respiratory diseases whose lungs are infected by Aspergillus fungi and Candida yeasts. PC945 may be useful in treating patients infected with Aspergillus as, unlike the usual treatments, it is inhaled into the lung and has been designed to stay there and treat the infection. Participants will continue to receive their usual treatment for their chronic respiratory disease. Half of the participants will receive PC945 and half will receive a placebo. The amount of fungus and yeast in the patients' phlegm will be measured over the course of the study. The study will take place at multiple sites in UK and will include approximately 46 participants. The maximum study duration will be about 16 weeks.