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

Theravance Biopharma

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: TD-8236

Study type: Interventional

Funder types: Industry

Identifiers

NCT04150341

0178

2019-002915-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

TD-8236 Dose A (low dose)

Experimental group

Description:

TD-8236 Dose A (QD x 14 days)

Treatment:

Drug: TD-8236

TD-8236 Dose B (high dose)

Experimental group

Description:

TD-8236 Dose B (QD x 14 days)

Treatment:

Drug: TD-8236

Placebo

Placebo Comparator group

Description:

Placebo (QD x 14 days)

Treatment:

Drug: Placebo