Phase 2
N=24
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT04150341 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: 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 — -0.53; -0.54; -0.57 liters — p=0.881
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TD-8236 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theravance Biopharma
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-0.53; -0.54; -0.57 | 0.881 |
| SECONDARY 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 |
-16.92; -17.50; -17.97 | — |
| SECONDARY Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14 |
-0.83; -0.86; -0.85 | — |
| SECONDARY Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14 |
-27.02; -28.18; -26.88 | — |
| SECONDARY Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma |
0.482; 1.54 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval |
0.0207; 0.160 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval |
0.950; 0.550 | — |
| SECONDARY Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) |
10; 9; 9; 3; 3; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT04150341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.