NCT04150341

Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response

A Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study to Evaluate the Effects of Repeated Doses of Inhaled TD-8236 and Impact on Airway Responses Following Allergen Challenge in Patients With Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This will be a randomized, double-blind, placebo-controlled study. The study will use a three-period, six-sequence, complete-block, cross-over study design to characterize two doses of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to an allergen. Each of the three periods will be 14 days, followed by a washout period before the next period.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	TD-8236	The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
DRUG	Placebo	The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

Timeline

• Start date: 2019-11-06
• Primary completion: 2020-08-28
• Completion: 2020-09-03
• First posted: 2019-11-04
• Last updated: 2022-03-18
• Results posted: 2022-03-18

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study