NCT03281941

ToAST:Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma

ToAST: Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: National Health Service, United Kingdom · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

ToAST study is a pilot study aiming to establish the safety profile of using inhaled capsaicin challenge in patients with severe asthma. The investigators will also explore the differences in cough symptoms and threshold in patients with and without bronchial thermoplasty.

Detailed description

ToAST is designed as a two-visit observational study. During visit 1, written consent and measurements of baseline asthma characteristics were completed; history and examination, questionnaires (Asthma Control Questionnaires and Leicester Cough Questionnaire, and basic lung physiological assessment were performed. At the end of visit 1, a cough monitor was attached to the subject to monitor cough frequency for the next 24 hours and this was returned at visit 2. Visit 2 followed within two weeks after visit 1, during which a full dose capsaicin cough challenge was performed. Emergency contact details were given towards end of visit 2 should any adverse events occur. Telephone call within 48 hours, Day 3 and Day 7: The purpose of these phone calls was to ensure that the patient had not developed any adverse effects to the capsaicin challenge.

Conditions

• Asthma Chronic, Cough

Interventions

Type	Name	Description
OTHER	Inhaled capsaicin cough challenge

Timeline

• Start date: 2016-08-06
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2017-09-13
• Last updated: 2017-09-13

Locations

1 site across 1 country: United Kingdom