An Open Label Oxygen Enhanced Imaging Biomarker Study in Moderate to Severe Asthma.

Phase 1

• Conditions: Asthma; MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-000172-98-GB
• Lead Sponsor: The University of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 17

Inclusion Criteria

Inclusion Criteria for Asthma Patients

•Asthma
•Aged 18-70 years
•GINA treatment steps 3/4
•Physician diagnosis and one or more of the following (i) PC20 = 8 mg/ml, (ii) bronchodilator reversibility FEV1 > 12%/200mls, (iii) Peak flow variability of = 20% over 2 weeks
•Post-bronchodilator FEV1% predicted of = 60% and an FEV1/FVC ratio of < 70%
•Willing and able to give informed consent

Inclusion Criteria for Healthy Volunteers

•No prior history of respiratory disease or symptoms
•Aged 18-70 years
•Normal spirometry and methacholine PC20 = 16 mg/ml
•Willing and able to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion Criteria for Asthma Patients

* Exacerbation within the previous 6 weeks requiring oral steroids
* Concurrent leukotriene receptor antagonist or theophylline
* Non reversible active lung disease e.g. bronchiectasis
* Current smoker/ = 10 pack year smoking history
* Use of beta blocker, tricyclic antidepressant, mono amine oxidase inhibitor, quinidine type anti arrhythmic, or potent CYP3A4 inhibitors within the past week
* Unable to provide informed consent
* Pregnancy or lactating at the time of consent (or) if identified as pregnant by a pregnancy test during the first study visit.
* History of poor treatment adherence
* Claustrophobia
* Metallic implants/screen failure on MRI safety questionnaire
* <18 years or >70 years

Exclusion Criteria for Healthy Volunteers

Non reversible active lung disease e.g. bronchiectasis
Current smoker/ = 10 pack year smoking history
Use of beta blocker, tricyclic antidepressant, mono amine oxidase inhibitor, quinidine type anti arrhythmic, or potent CYP3A4 inhibitors within the past week
Unable to provide informed consent
Pregnancy or lactating at the time of consent (or) if identified as pregnant by a pregnancy test during the first study visit.
Claustrophobia
Metallic implants/screen failure on MRI safety questionnaire
<18 years or >70 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified