Mechanisms of Adverse Effects of Long-Acting Beta-Agonists in Asthma

Who is this study for? Patients with asthma
What treatments are being studied? Salmeterol Xinafoate+Salmeterol Fluticasone
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study aims to elucidate the pathophysiological mechanisms underlying the adverse effects associated with the use of long-acting beta-agonists (LABAs) in asthma. Participants with mild asthma will be enrolled into a single-arm, unblinded trial in which they receive 2 weeks of salmeterol xinafoate monotherapy, followed by a 2-week washout period, followed by 2 weeks of salmeterol xinafoate / fluticasone propionate combination therapy. The induction of asthma disease-relevant pro-inflammatory mediators in the airways will be measured at each stage and correlated with relevant clinical parameters.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years

• A doctor's diagnosis of asthma (mild in severity)

• 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

• Pre-bronchodilator FEV1 value \> 70% of the predicted value

Locations
Other Locations
United Kingdom
St Mary's Hospital, Imperial College Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Sebastian L Johnston, MBBS PhD FRCP FRSB FMedSci
s.johnston@imperial.ac.uk
+44 20 7594 3764
Backup
Eva Fiorenzo, BMBS
e.fiorenzo@imperial.ac.uk
+44 20 7594 3751
Time Frame
Start Date: 2021-07-23
Completion Date: 2024-09-30
Participants
Target number of participants: 24
Treatments
Experimental: Single treatment arm
All participants who are deemed eligible for inclusion in the study following screening will be enrolled into a single experimental arm which will comprise the following sequential stages:~1. Baseline sampling; participants only use 'as required' ipratropium bromide when needed (1 week)~2. Salmeterol xinafoate monotherapy 50 μg twice in the morning and twice in the evening + 'as required' ipratropium bromide when needed (2 weeks)~3. Washout period; participants only use 'as required' ipratropium bromide when needed (2 weeks)~4. Salmeterol xinafoate 50 μg / fluticasone propionate 250 μg combination therapy twice in the morning and twice in the evening + 'as required' ipratropium bromide when needed (2 weeks)
Related Therapeutic Areas
Sponsors
Collaborators: European Research Council
Leads: Imperial College London

This content was sourced from clinicaltrials.gov