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Asthma clinical trials

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NCT ID: NCT04048343 Completed - Severe Asthma Clinical Trials

Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma

NOZOMI
Start date: June 10, 2019
Phase: Phase 3
Study type: Interventional

This is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with inadequately controlled severe asthma.

NCT ID: NCT04046939 Completed - Asthma Clinical Trials

Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma

EXHALE-1
Start date: August 15, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma.

NCT ID: NCT04032834 Completed - Asthma Clinical Trials

A Comparison of VR647 and Conventionally Nebulized Budesonide in Healthy Volunteers and Adult Asthma Subjects

Start date: February 20, 2017
Phase: Phase 1
Study type: Interventional

This is a three part, randomized, open-label, crossover, Phase 1 trial in adults. Parts 1 and 2 will enroll healthy male and female subjects. Part 3 will enroll subjects with mild asthma. This study will assess the pharmacokinetics, safety and tolerability of single doses of budesonide delivered by VR647 Inhalation System (AKITA® JET) with mouthpiece or face mask to single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS®) with mouthpiece or face mask.

NCT ID: NCT04031261 Completed - Asthma Clinical Trials

National Validation and Sensitivity to Change of the SAQ

Start date: April 10, 2019
Phase:
Study type: Observational

DESIGN A multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data. AIMS To collect further quantitative data to validate a new asthma quality of life scale, the Severe Asthma Questionnaire (SAQ). To determine the Minimum Clinically Important Difference (MCID) of the SAQ OUTCOME MEASURES Questionnaires: 1. The Severe Asthma Questionnaire (SAQ) 2. The Mini Asthma Quality of Life Questionnaire (MiniAQLQ) 3. The EQ-5D-5L 4. The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ) 5. Global Rating of Change Questionnaire (GRCQ) Clinical data comprises: 6. Spirometry 7. BMI 8. Asthma severity 9. Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the last 12 months; 10. Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if oral steroid dependent). POPULATION All patients aged 16 years or over, who have attended one of three participating UK specialist asthma centres for the validation study and with data also collected from Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important difference. ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma DURATION 18 months

NCT ID: NCT04022447 Completed - Severe Asthma Clinical Trials

Dupilumab for Severe Asthma in a Real Life Setting

DUPI-France
Start date: August 10, 2018
Phase:
Study type: Observational

Dupilumab is a monoclonal anti-IL-4/13Rα antibody developed for severe asthma (SA). In France, mepolizumab was commercialized in February 2018. Before this date, many SA patients had reached a therapeutic dead end, with uncontrolled disease despite maximal available treatment. Upon the request of lung specialists involved in SA, French health authorities approved an early access program (temporary Use Authorization) allowing early access to dupilumab (before EMA's decision) from September 2017 to January 2018, for SA patients demonstrating unacceptable steroids side effects and/or life-threatening exacerbations, irrespective of their T2 status.The aim of this retrospective study was to describe the characteristics of SA patients included in the early access program and to assess changes in asthma control after a 12 months treatment.

NCT ID: NCT04007198 Completed - Asthma Clinical Trials

A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma

EQUIP
Start date: June 20, 2019
Phase: Phase 1
Study type: Interventional

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with moderate-to-severe asthma.

NCT ID: NCT04003415 Completed - Asthma Clinical Trials

Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

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

This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. We propose to study whether the device's measurements are accurate and reproducible in patients with chronic obstructive pulmonary disease (COPD) or asthma. The device undergoing study has been evaluated in healthy volunteers, but its accuracy in vital sign monitoring in patients with respiratory conditions has not yet been established. This study will serve as the foundation for additional work to assess the device's accuracy in measuring a patient's overall "work of breathing" or respiratory effort. Future work will examine the device's accuracy in measuring work of breathing in patients having an exacerbation of their underlying respiratory condition. The primary aim of this study will be to assess the validity of heart rate and respiratory rate measurements in patients with either COPD or asthma.

NCT ID: NCT04002427 Completed - Asthma Clinical Trials

Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594

Start date: June 11, 2019
Phase: Phase 1
Study type: Interventional

AZD7594 is in clinical development for the treatment of asthma. This is a single centre, open-label, single period study in 6 healthy subjects, to determine the mass balance recovery and generate samples to enable metabolite profiling and structural identification of AZD7594. Each subject will receive a single inhaled 792 µg nominal dose (720 µg delivered dose) of AZD7594 followed by an IV dose of 30 µg [14C]AZD7594 containing not more than (NMT) 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 h infusion. The IV dose will be administered approximately 10 min after the inhaled dose. Subjects will remain resident in the clinical unit up to 168 h post dose (up to Day 8).

NCT ID: NCT03999242 Completed - Asthma Clinical Trials

Charcot Leyden Crystals in Pathology

CLCpath
Start date: April 1, 2019
Phase:
Study type: Observational

Charcot Leyden crystals (CLC) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. The investigators organized a retrospective analysis of all consecutive patients with CLC seen at our institution between 1986 and 2019

NCT ID: NCT03999203 Completed - Asthma Clinical Trials

A Cross-sectional Study to Measure Cough in Severe Asthma

CISA
Start date: October 4, 2017
Phase: N/A
Study type: Interventional

This study aims to characterise cough in severe asthma through an observational cross-sectional analysis of patients stratified by inflammatory biomarker profile using a number of subjective and objective cough measurement tools.