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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150341
Recruitment Status : Completed
First Posted : November 4, 2019
Results First Posted : March 18, 2022
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: TD-8236 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 6, 2019
Actual Primary Completion Date : August 28, 2020
Actual Study Completion Date : September 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: TD-8236 Dose A (low dose)
TD-8236 Dose A (QD x 14 days)
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.

Experimental: TD-8236 Dose B (high dose)
TD-8236 Dose B (QD x 14 days)
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 Comparator: Placebo
Placebo (QD x 14 days)
Drug: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150341


Locations
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United Kingdom
Theravance Biopharma Investigational Site
London, United Kingdom, W1G 8HU
Theravance Biopharma Investigational Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma
  Study Documents (Full-Text)

Documents provided by Theravance Biopharma:
Study Protocol  [PDF] November 5, 2019
Statistical Analysis Plan  [PDF] September 21, 2020

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT04150341    
Other Study ID Numbers: 0178
2019-002915-24 ( EudraCT Number )
First Posted: November 4, 2019    Key Record Dates
Results First Posted: March 18, 2022
Last Update Posted: March 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Theravance Biopharma:
TD-8236
Asthma
Proof of concept
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases