AsthmaPhase 2NCT04150341
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
A Phase 2 study testing TD-8236 in people with Asthma, run by Theravance Biopharma at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- TD-8236
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Nov 2019to 3 Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Pre-bronchodilator FEV1 ≥ 70% predicted
- Documented allergy to at least one common allergen
- Dual responder to inhaled bronchial challenges
- Additional inclusion criteria apply
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Theravance Biopharma Investigational Site
London, W1G 8HU
Theravance Biopharma Investigational Site
Manchester, M23 9QZ
About this study
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
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.
- Conditions
- Asthma
- Being tested
- TD-8236, Placebo
- Keywords
- TD-8236, Asthma, Proof of concept
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-8236Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TD-8236 Dose A (low dose) | Experimental | TD-8236 Dose A (QD x 14 days) Receives: Drug: TD-8236 |
| TD-8236 Dose B (high dose) | Experimental | TD-8236 Dose B (QD x 14 days) Receives: Drug: TD-8236 |
| Placebo | Placebo comparator | Placebo (QD x 14 days) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14 of treatment period: 3 to 8 hours after allergen challenge
Secondary outcomes (7)
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.
Measured: Day 14 of treatment period: 3 to 8 hours after allergen challenge
Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
Measured: Day 14 of treatment period: 3 to 8 hours after allergen challenge
Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
Measured: Day 14 of treatment period: 3 to 8 hours after allergen challenge
Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma
Measured: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval
Measured: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval
Measured: Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
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.
Measured: Day 1 to end of follow-up (up to approximately 98 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start6 Nov 2019
- Primary completion28 Aug 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150341
- Sponsor's protocol ID
- 0178
- Other IDs
- 2019-002915-24, 2019
- Status last verified
- Feb 2022
- First submitted
- 15 Oct 2019
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04150341
- Acronym / sponsor ID
- 0178
- Conditions
- Asthma
- Keywords
- TD-8236, Asthma, Proof of concept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 18 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TD-8236 Dose A (low dose) | Experimental | Drug: TD-8236TD-8236 Dose A (QD x 14 days) |
| TD-8236 Dose B (high dose) | Experimental | Drug: TD-8236TD-8236 Dose B (QD x 14 days) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (QD x 14 days) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD-8236The 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. | Drug | TD-8236 Dose A (low dose), TD-8236 Dose B (high dose) |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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
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
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TD-8236 in people with Asthma, run by Theravance Biopharma at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.