scholarly journals Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Francisco Mera Cordero ◽  
Sara Bonet Monne ◽  
Jesús Almeda Ortega ◽  
Ana García-Sangenís ◽  
Oriol Cunillera Puèrtolas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Functional Status ◽  
Exercise Capacity ◽  
Respiratory Symptoms ◽  
Double Blind ◽  
Mental Confusion ◽  
Link Type ◽  
Copd Assessment Test

Abstract Background The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable. Objectives To evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality. Methods and analysis Phase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast. Ethics and dissemination This study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals. Trial registration ClinicalTrials.govNCT04695704. Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.

scholarly journals Double-blind Placebo-controlled Randomized Clinical Trial to Assess the Efficacy of Montelukast in Mild to Moderate Respiratory Symptoms of Patients With Long COVID E-SPERANZA COVID PROJECT Study Protocol

2021 ◽  
Author(s):  
Francisco Mera-Cordero ◽  
Sara Bonet Monne ◽  
Jesús Almeda Ortega ◽  
Ana García-Sangenís ◽  
Oriol Cunillera Puèrtolas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Functional Status ◽  
Exercise Capacity ◽  
Respiratory Symptoms ◽  
Double Blind ◽  
Old Patients ◽  
Mental Confusion ◽  
Copd Assessment Test

Abstract BackgroundThe coronavirus disease-2019 (COVID-19) pandemic continues to affect the globe. After eighteen months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown and evidence-based, effective treatments for this condition remain unavailable. ObjectivesTo evaluate the efficacy of 10 mg oral montelukast every 24 hours versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving: exercise capacity; COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia); oxygen desaturation during exertion; functional status; and mortality. Methods and analysisPhase III, randomized, double-blind clinical trial. We will include 18 to 80 year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow up will finish 56 days after start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting treatment. Secondary outcomes a) Exercise capacity and oxygen saturation (1Min Sit-to-Stand test); b) Post-COVID-19 Functional Status scale; c) Other symptoms: asthenia, headache, mental confusion (brain fog), ageusia and anosmia (Likert scale); d) Use of healthcare resources; e) Mortality; f) Sick leave duration in days g) Side effects of montelukast. Ethics and disseminationThis study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals. Trial registrationClinicalTrials.gov Identifier: NCT04695704 first posted on January, 5, 2021. EudraCT number 2021-000605-24). Prospectively registered.

scholarly journals Preventive effect of oral magnesium in postmastectomy pain: protocol for a randomised, double-blind, controlled clinical trial

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e017986 ◽  
Author(s):  
Véronique Morel ◽  
Dominique Joly ◽  
Christine Villatte ◽  
Bruno Pereira ◽  
Gisèle Pickering
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Type I ◽  
Preventive Effect ◽  
Double Blind ◽  
Link Type ◽  
Oral Magnesium

IntroductionBreast cancer affects 1 in 10 women worldwide, and mastectomy is a cause of chronic pain with neuropathic characteristics.N-methyl-D-aspartate receptor (NMDAR) antagonists such as ketamine, memantine, dextromethorphan or magnesium are used to treat refractory pain by blocking NMDAR. Oral memantine has been shown to prevent postmastectomy pain and cognitive impact and to maintain quality of life. Likewise, the present study is intended to assess the preventive effect of oral magnesium, administered ahead of mastectomy, on the development of neuropathic pain. As a physiological blocker of NMDAR, magnesium could be an interesting candidate to prevent postoperative pain and associated comorbidities, including cognitive and emotional disorders, multiple analgesic consumption and impaired quality of life.Methods and analysisA randomised double-blind controlled clinical trial (NCT03063931) will include 100 women with breast cancer undergoing mastectomy at the Oncology Hospital, Clermont-Ferrand, France. Magnesium (100 mg/day; n=50) or placebo (n=50) will be administered for 6 weeks, starting 2 weeks before surgery. Intensity of pain, cognitive and emotional function and quality of life will be assessed by questionnaires. The primary endpoint is pain intensity on a 0–10 numerical rating scale at 1 month postmastectomy. Data analysis will use mixed models; all tests will be two-tailed, with type-I error set at α=0.05.Ethics and disseminationThe study protocol and informed consent form were approved in December 2016 by the French Research Ethics Committee (South East VI Committee). Results will be communicated in various congresses and published in international publications.Trial registration numberNCT03063931.

Oral Propolis, Nutritional Status and Quality of Life with Chemotherapy for Breast Cancer: A Randomized, Double-Blind Clinical Trial

2021 ◽  
pp. 1-9
Author(s):  
Seyed Hossein Davoodi ◽  
Vahid Yousefinejad ◽  
Bayazid Ghaderi ◽  
Mohammad Esmail Akbari ◽  
Shoaleh Darvishi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Nutritional Status ◽  
Double Blind ◽  
Double Blind Clinical Trial

scholarly journals 2477 Targeting pulsatile load to increase exercise capacity and quality of life after TAVR for severe aortic stenosis

2018 ◽  
Vol 2 (S1) ◽  
pp. 48-48
Author(s):  
Anupam Kumar ◽  
Julio Chirinos
Keyword(s):  
Quality Of Life ◽  
Aortic Stenosis ◽  
Exercise Capacity ◽  
Severe Aortic Stenosis ◽  
Myocardial Strain ◽  
Study Drug ◽  
Potassium Nitrate ◽  
Exercise Intolerance ◽  
Double Blind

OBJECTIVES/SPECIFIC AIMS: The objective of the study is to test the effect of oral inorganic nitrate on the primary outcomes of exercise capacity and quality of life in patients who have undergone TAVR for severe aortic stenosis. We will also test the effect of the study drug on various physiology endpoints, including systemic vasodilator response to exercise, LV diastolic function and myocardial strain, late systolic LV load and pulsatile arterial wave reflections. METHODS/STUDY POPULATION: This is a randomized double-blind crossover clinical trial, in which 24 subjects who underwent TAVR for severe AS 3 or more months before enrollment will receive the following 2 interventions, in randomized order: (1) Potassium nitrate (KNO3), at a dose of 12–18 mmol/day by mouth for ~4 weeks, or (2) Potassium chloride (KCl), at a dose of 12–18 mmol/day by mouth for ~4 weeks. A 1-week washout period will be introduced between the 2 interventions. RESULTS/ANTICIPATED RESULTS: We hypothesize that sustained oral administration of potassium nitrate will lead to improvement of exercise capacity and quality of life in this population.DISCUSSION/SIGNIFICANCE OF IMPACT: His study will have a significant impact on assessment and management of patients after TAVR. We will gain a better understanding of physiologic abnormalities leading to exercise intolerance after TAVR. In addition, there are currently no proven therapies that improve exercise capacity in this population.

scholarly journals A combination of mupirocin and acidic fibroblast growth factor for nipple fissure and nipple pain in breastfeeding women: protocol for a randomised, double-blind, controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025526
Author(s):  
Xiaofang Lv ◽  
Rui Feng ◽  
Jingbo Zhai
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Growth Factor ◽  
Fibroblast Growth Factor ◽  
Treatment Period ◽  
Current Evidence ◽  
Fibroblast Growth ◽  
Acidic Fibroblast Growth Factor ◽  
Double Blind

IntroductionNipple fissure and nipple pain are common complaints among breastfeeding mothers. Studies found that mupirocin was effective in preventing and treating infections of damaged nipple and nipple pain. Acidic fibroblast growth factor (aFGF) plays an important role in wound healing. However, current evidence on the efficacy and safety of mupirocin plus aFGF for nipple fissure and nipple pain in breastfeeding women is inconclusive due to the lack of well-designed randomised controlled trials on this topic. The purpose of this study is to test the hypothesis that mupirocin plus aFGF is more effective than mupirocin alone for nipple fissure and nipple pain in breastfeeding women.Methods and analysisThis study is a randomised, double-blind, single-centre, parallel-group clinical trial. A total of 120 breastfeeding women with nipple fissure and nipple pain will be randomly assigned to either mupirocin plus aFGF group or mupirocin plus placebo group according to a computer-generated random allocation sequence. The treatment period lasts 14 days. The primary outcome is nipple pain intensity measured by the Visual Analogue Scale on day 14 during the treatment period. Secondary outcome measures include time to complete nipple pain relief, changes in the Nipple Trauma Score, time to complete healing of nipple trauma, quality of life measured by the Maternal Postpartum Quality of Life (MAPP-QOL) Questionnaire, the frequency of breast feeding, the rate of breastfeeding discontinuation, weight change in infants and adverse events.Ethics and disseminationThe study has gained approval from the Ethics Review Committee of Tianjin Central Hospital of Gynaecology Obstetrics on 22 January 2018 (approval no. 2018KY001). We plan to publish our research findings in a peer-reviewed academic journal and disseminate these findings in international conferences. This study has been registered with the Chinese Clinical Trial Registry.Trial registration numberChiCTR1800017248.

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