A study to explore why certain types of inhaled medications cause an increased risk of worse outcomes among asthma patients

Phase 1

• Conditions: Asthma; MedDRA version: 21.1Level: LLTClassification code 10003638Term: Atopic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: LLTClassification code 10003565Term: AsthmaticSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: LLTClassification code 10015575Term: Exacerbation of asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-003036-23-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-03
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1) Aged 18 years and above
2) A doctor’s diagnosis of asthma (mild in severity)
3) No current regular asthma treatment or regular asthma treatment in the preceding 6 weeks; only a history of using short-acting bronchodilator inhalers on demand is allowed
4) Pre-bronchodilator FEV1 value greater than or equal to 80% of the predicted value
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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1) History or evidence of chronic respiratory disease other than asthma
2) History or evidence of other disease, blood test results outside the normal reference range or medication use that would impair the ability of participants to safely undertake the study or the ability of researchers to interpret the study results; this includes, but is not limited to, the use of anticoagulants (e.g. warfarin), adenosine diphosphate (ADP) receptor inhibitors (e.g. clopidogrel), antiretroviral therapy (due to the potential for interaction with fluticasone), certain antifungal agents (due to the potential for interaction with fluticasone) and beta-blockers
3) Current use or use in the last 6 weeks of systemic or nasal topical steroids, inhaled corticosteroids or systemic immunosuppressants
4) Platelet count < 150 x 109/L or international normalised ratio (INR) > 1.5
5) History of smoking > 5 pack years, current smoker or history of smoking in the last 4 weeks
6) Current vaping or history of vaping in the last 4 weeks
7) Current illicit drug use/abuse
8) Abnormal chest x-ray appearance
9) Signs or symptoms of upper respiratory tract infection or lower respiratory tract infection in the preceding 6 weeks
10) Cardiac conduction abnormalities on electrocardiogram (ECG)
11) Current pregnancy or planning to become pregnant during the study period
12) Breastfeeding during the study period
13) Inability to provide informed consent to participate in the study
14) Current involvement in any other clinical research studies involving medicinal products or devices; or involvement in clinical research studies involving medicinal products within 5 half-lives of the medicinal product
15) Inability to speak English or inability to understand verbal or written English
16) Inability to attend hospital for all scheduled study visits
17) Hypersensitivity to any of the investigational medicinal products (IMPs) or their excipients

Study & Design

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