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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150341
• Other study ID #: 0178
• Secondary ID: 2019-002915-24
• Status: Completed
• Phase: Phase 2
• Start date: November 6, 2019
• Est. completion date: September 3, 2020

Study information

• Verified date: February 2022
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 3, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• TD-8236
The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
• Placebo
The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

Locations

Country	Name	City	State
United Kingdom	Theravance Biopharma Investigational Site	London
United Kingdom	Theravance Biopharma Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	Day 14 of treatment period: 3 to 8 hours after allergen challenge
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	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.	Day 14 of treatment period: 3 to 8 hours after allergen challenge
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	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.	Day 1 to end of follow-up (up to approximately 98 days)