Clinical trial NCT04150341: Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: TD-8236
Asthma
Proof of concept
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 65 years of age
* Willing and able to give informed consent and comply with study requirements
* Documented physician-diagnosed asthma for ≥ 4 months prior to Screening
* Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at Screening.
* Women of child bearing potential must have a negative pregnancy test
* Males and females must use a highly efficient birth control method
* Pre-bronchodilator FEV1 ≥ 70% predicted
* Documented allergy to at least one common allergen
* Dual responder to inhaled bronchial challenges
* Additional inclusion criteria apply

Exclusion Criteria:

* Positive for hepatitis A, B or C, HIV or tuberculosis
* Clinically significant abnormalities of laboratory evaluations
* Have abnormal ECG measurements
* Any sign of respiratory tract infection within 6 weeks of screening
* Have a current bacterial, parasitic, fungal or viral infection
* History of life-threatening asthma
* Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
* Additional exclusion criteria apply

Primary outcomes:
measure: Area Under the Curve of Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
timeFrame: Day 14 of treatment period: 3 to 8 hours after allergen challenge
Secondary outcomes:
measure: Area Under the Curve of Percentage Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
timeFrame: Day 14 of treatment period: 3 to 8 hours after allergen challenge
measure: Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
timeFrame: Day 14 of treatment period: 3 to 8 hours after allergen challenge
measure: Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
timeFrame: Day 14 of treatment period: 3 to 8 hours after allergen challenge
measure: Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma
timeFrame: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval
timeFrame: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
measure: Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval
timeFrame: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
measure: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 to end of follow-up (up to approximately 98 days)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Theravance Biopharma Investigational Site
city: Manchester
country: United Kingdom
facility: Theravance Biopharma Investigational Site
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: