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Completed

NCT Number: NCT04150341

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Theravance Biopharma Investigational Site, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD-8236

Drug

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

Drug

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.

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

    Time frame: Day 14 of treatment period: 3 to 8 hours after allergen challenge

  3. Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

    Time frame: Day 14 of treatment period: 3 to 8 hours after allergen challenge

  4. Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma

    Time frame: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose

  5. Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval

    Time frame: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose

  6. Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval

    Time frame: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose

  7. Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 4, 2019
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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