Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
- Conditions
- Asthma
- Interventions
- Drug: TD-8236Drug: Placebo
- Registration Number
- NCT04150341
- Lead Sponsor
- Theravance Biopharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TD-8236 Dose A (low dose) TD-8236 TD-8236 Dose A (QD x 14 days) TD-8236 Dose B (high dose) TD-8236 TD-8236 Dose B (QD x 14 days) Placebo Placebo Placebo (QD x 14 days)
- Primary Outcome Measures
Name Time Method 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 Day 14 of treatment period: 3 to 8 hours after allergen challenge Values are reported as a weighted mean derived by calculating the AUC change from baseline over the relative time interval, divided by the time interval.
- Secondary Outcome Measures
Name Time Method 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 Day 14 of treatment period: 3 to 8 hours after allergen challenge Values are reported as a weighted mean derived by calculating the AUC percentage change from baseline over the relative time interval, divided by the time interval.
Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14 Day 14 of treatment period: 3 to 8 hours after allergen challenge Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14 Day 14 of treatment period: 3 to 8 hours after allergen challenge Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Day 1 to end of follow-up (up to approximately 98 days) A TEAE was defined as any adverse event (AE) that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period.
The severity of TEAEs were also assessed and were classified as mild, moderate or severe per the definitions below:
Mild - The AE is noticeable to the participant and/or the investigator, but does not interfere with routine activity.
Moderate - The AE interferes with routine activity, but responds to symptomatic therapy or rest.
Severe - The AE significantly limits the participant's ability to perform routine activities despite symptomatic therapy.
Trial Locations
- Locations (1)
Theravance Biopharma Investigational Site
🇬🇧Manchester, United Kingdom