Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions...
Respiratory DisordersAsthma and RhinitisThis study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator product) in healthy adult volunteers under fasting conditions. This is an open-label, balanced, randomized, single dose, two-way crossover study, enrolling 32 healthy human subjects to ensure at least 28 subjects complete the study. Each subject enrolled will participate in two treatment periods separated by a washout period of at least 7 days and no more than 14 days between dosing occasions. Total duration in the study for each subject will be approximately 7 weeks from screening to the subject's last visit.
Collaborative Care With Smart Health Management Program for Patients With Chronic Illness
OsteoporosisChronic Respiratory Disease2 moreThis study verifies efficacy of collaborative care with Smart Health Management Program developed for patients with chronic illness. The aim of the study is to observe the changes in clinical indicators, quality of life and health related behaviors when providing self-management programs with ICT for chronic disease patients.
The Effect of an AEP on Patient's Knowledge Regarding Asthma Disease and Inhaler Technique: RCT...
Chronic Respiratory DiseaseAsthma is an important chronic disease that causes a significant public health problem and the commonest medical conditions treated in health clinics giving rise to considerable morbidity and mortality. Several studies suggested that improvement of patient knowledge has become a key component of asthma management. In the study setting the education material for Asthma patient is available however the proper cannel to deliver it to patient remains a puzzle to the researcher, therefore this study is trying to close the gap between Asthma education material and patient.The aim of the study is to investigate the effectiveness of an Asthma Education Program (AEP) result in improvement of patient's knowledge, medication adherence and inhaler technique.This is an experimental study a clinical trials. Data will be gathered utilising three an adapted instrument to assess patient knowledge of their disease, medication adherence and inhaler technique. Patients who are came to Asthma Bay in Emergency Department, Respiratory Clinic for routine follow up and admitted to ward will be recruited as study subjects. Subject who are agree to enrol in the study will be randomized into intervention and control group. Subjects in intervention group will be undergone one session of an AEP, however there are no intervention for control group but continue routinely follow up in Respiratory Clinic. To obtain the study result descriptive and inferential statistical analysis will be performed. To analyse the statistical significant of the change in patients' health outcome the pre and post of AEP independent t-test or chi-square test will be used.The expected finding of this study is to determine the effectiveness of AEP result in of patients' knowledge regarding asthma disease, medication adherence and inhaler technique, pre and post of AEP. Keywords: asthma, asthma education program.
Home-based Exercise Training for COPD Patients (HOMEX-2)
Chronic DiseaseLung Diseases2 moreThe aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.
Home-based Exercise Training for COPD Patients
Chronic DiseaseLung Diseases2 moreThe aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation.
Evaluation of the Post-vaccination Immune Response to COVID-19 in the New Caledonian Population...
SARS-CoV-2 Acute Respiratory DiseaseThe COVID-19 pandemic caused by SARS-CoV-2 since December 2019 has caused more than 210 million cases worldwide as of September 1, 2021. New Caledonia (NC) is an ultramarine French territory in the South Pacific so far relatively spared by this pandemic thanks to the establishment of a health lock. The vaccination campaign started locally on 20/01/2021 with the exclusive use of Pfizer's COMIRNATY mRNA vaccine. Vaccination is now offered to anyone over the age of 12. Vaccination against COVID-19 will be mandatory in New Caledonia as of October 31, 2021 for certain exposed populations and for the entire adult population as of December 31, 2021. Clinical trials of COVID-19 vaccines, including those of mRNA vaccines, have taken care to maintain ethnic diversity within their samples. Efficacy studies have not shown a significant difference in the efficacy of Pfizer COMIRNATY vaccine in white, black American, or Hispanic populations. The response of non-European non-Asian Oceanian populations to Pfizer COMIRNATY vaccination has not been specifically studied at this time. According to the 2019 census in New Caledonia, 41.2% of the population identified themselves as Kanak (Melanesian), 24% as European, 8.3% as Wallisian-Futunian (Polynesian), 11% as mestizo, and 8% as belonging to other communities including Tahitian (Polynesian), Indonesian, Ni-Vanuatu (Melanesian), and Vietnamese communities (8). Some recent data are in favor of a significant variability of susceptibility to pathogens in Oceanian populations, stemming from a genetic inheritance from Neanderthal man and his cousin Denisova man. In a context of vaccine hesitancy, it is therefore important to ensure that the immune response of the New Caledonian population (Melanesian, Polynesian, European or other communities) to vaccination against COVID-19 is similar to that of populations studied in large clinical trials.
The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults...
Chronic Obstructive Pulmonary DiseaseThe objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.
Endotracheal Dilator to Improve Oxygenation
Tracheal StenosisAirway Disease1 moreThe purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator in children (<13 years old) with subglottic or tracheal stenosis. The hypothesis is that the device will effectively dilate the stenotic segment, whilst maintaining oxygenation (if applicable). The primary aim is to measure the stenosis prior to, and after dilatation; using diameter and the modified Myer-Cotton grading system. Secondary aims include assessment of stenosis at six-week follow-up and monitoring arterial oxygenation nadir (using peripheral plethysmography) during the procedure.
Effect of Vojta Therapy on Covid-19 Respiratory Disease
COVID-19 Acute Respiratory Distress SyndromeVojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. The non-invasive and non-painful technique consists of applying tolerable pressure to specific areas of the patient's body. The objective is to activate, in a reflex way, the ventilatory physiology. It is compared with the conventional respiratory physiotherapy approach.
Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized...
SARS-CoV-2 Acute Respiratory DiseaseSARS-CoV2 Infection1 moreTo explore the efficacy of treatment of pulmonary cytokine storm induced by SARS-CoV2 with a monoclonal antibody to IL-2 (Basiliximab) in addition to current standard of care vs current standard of care with the primary efficacy endpoint being the proportion of subjects alive and free of ventilator support, defined as intubation and requiring mechanical ventilation, at Day 28 from time of randomization.