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

Phase 2
Completed
Conditions
Asthma
Interventions
Drug: TD-8236
Drug: 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
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
TD-8236 Dose A (low dose)TD-8236TD-8236 Dose A (QD x 14 days)
TD-8236 Dose B (high dose)TD-8236TD-8236 Dose B (QD x 14 days)
PlaceboPlaceboPlacebo (QD x 14 days)
Primary Outcome Measures
NameTimeMethod
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 14Day 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
NameTimeMethod
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 14Day 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 PlasmaDay 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 14Day 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 14Day 14 of treatment period: 3 to 8 hours after allergen challenge
Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing IntervalDay 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 IntervalDay 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

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