AsthmaPhase 1NCT07272135
Selective β2-AR Antagonism in Asthma
A Phase 1 study testing TR4 in people with Asthma, run by Trio Medicines Ltd. at 1 site in United Kingdom.
Trial summary
The objectives are to assess the safety, tolerability and effect on the airways of TR4 in patients with mild-to-moderate asthma. The Phase 1 trial is randomised, double-blind, placebo-controlled, and ascending-dose in design. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- TR4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2018to 16 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women
- Minimum 21 years old
- History of mild-to-moderate asthma for at least 6 months and controlled by an inhaled SABA, as required
- Otherwise healthy
- Ideally have participated in previous asthma studies
- No corticosteroid for whatever reason within 8 weeks of the start of dosing
Show all 13Show fewer
- No other prescription medicine within 28 days (apart from a short acting beta-agonist (SABA) or contraceptives in women)
- No over-the-counter medicine within 7 days (apart from acetaminophen) before the start of dosing
- Negative screen for drugs of abuse; forced expiratory volume in 1 second (FEV1) more than or equal to 70% predicted
- Fractional exhaled nitric oxide (FeNO) more than or equal to 35 ppb
- 15% fall in FEV1 after inhaled mannitol (PD15)
- Non-smoker or past smoker (<5 pack years)
- Substitution of subject's SABA inhaler with an anti-cholinergic inhaler, ipratropium bromide, for use as a reliever or rescue medication during a run-in period and during dosing with TR4 or placebo.
Who cannot join
- Positive test for hepatitis B \& C or HIV
- Drug or alcohol abuse
- Airway infection or asthma exacerbation in the last 4 weeks
- Current seasonal asthma
- History of emergency treatment of asthma
- Loss of more than 400 mL blood, or participation in other clinical trials of unlicensed medicines within the previous 3 months
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- Consumption of grapefruit or herbal remedies within the past 7 days
- Objection by the subject's general practitioner (GP)
- Subjects who are sexually active and not using reliable contraception
- Women who are lactating, pregnant or plan to become pregnant during the study period
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2 virus
- Subjects who have not received both doses of a COVID-19 vaccine.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research
London, London, NW10 7EW
About this study
Official title: A Double-blind, Placebo-controlled, Ascending-dose Study to Assess the Safety, Tolerability and Efficacy of TR4, a Selective β2-adrenoceptor (β2-AR) Antagonist, in Patients With Mild-to-moderate Asthma
The objectives are to assess the safety, tolerability and effect on the airways of TR4 in patients with mild-to-moderate asthma. The Phase 1 trial is randomised, double-blind, placebo-controlled, and ascending-dose in design.
Read the detailed description
After a run-in period of 2 weeks, 12 eligible patients will be randomised to treatment with either TR4 or placebo. Nine patients will take incremental doses of 2.5, 5, 10 and 20 mg of TR4 capsules, each dose three times daily for 7 days, and then 40 mg three times daily for 21 days, over a total period of 7 weeks. Three patients will take matching placebo capsules in a similar manner.
The number of visits and the types are as follows. There will be a maximum of 10 visits to Hammersmith Medicines Research (HMR) for those subjects who complete the whole study according to the protocol. Visit 1 is an out-patient visit for informed consent and screening. Visit 2 is a short out-patient visit at the start of a 2-week run-in period for those subjects who pass screening. After the run-in period, patients who are still eligible will be given a schedule for 8 further visits (Visits 3-10). Participants will stay on the ward for 2 nights during 5 of those visits (Visits 3-7), and for 1 night during Visit 10. Visits 8 and 9 are short out-patient visits. The study will take each subject ~10 weeks to complete. For purposes of data collection and management the study is divided into one session for screening, a run-in period and 5 treatment periods.
- Conditions
- Asthma
- Being tested
- TR4, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR4Drug
TR4 is a selective beta-2-adrenoceptor antagonist. TR4 will be weighed into opaque capsules and released for individual patients, in accordance with good manufacturing practice (GMP).
PlaceboOther
Placebo capsules will contain start in opaque capsules.
| Study group | Role | What they receive |
|---|---|---|
| TR4 | Experimental | After a run-in period of 2 weeks, 9 patients will be randomly assigned to the TR4 treatment arm. These 9 patients will take incremental doses of 2.5, 5, 10, and 20 mg of TR4, each dose three times daily for 7 days, and then 40 mg three times daily for 21 days, over a total period of 7 weeks. Receives: Drug: TR4 |
| Placebo | Placebo comparator | Three patients will take matching placebo capsules in a similar manner to TR4. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mannitol (PD15)
The dose of mannitol causing a 15% fall in FEV1
Measured: Baseline (day -1) of treatment periods 1 to 5.
Mannitol (PD15)
The dose of mannitol causing a 15% fall in FEV1
Measured: Day 21 of treatment period 5.
Spirometry (FEV1)
Lung function test: The forced expiratory volume in 1 second (FEV1).
Measured: Day 1 of treatment periods 1 to 5.
Spirometry (FEV1)
Lung function test: The forced expiratory volume in 1 second (FEV1).
Measured: Day 2 of treatment periods 1 to 5.
Spirometry (FEV1)
Lung function test: The forced expiratory volume in 1 second (FEV1).
Measured: Day 21 of treatment period 5.
Spirometry (FVC)
Lung function test: forced vital capacity (FVC)
Measured: Day 1 of treatment periods 1 to 5
Spirometry (FVC)
Lung function test: forced vital capacity (FVC).
Measured: Day 2 of treatment periods 1 to 5
Spirometry (FVC)
Lung function test: forced vital capacity (FVC).
Measured: Day 21 of treatment period 5
Spirometry (FEF 25-75)
Lung function test: forced mid-expiratory flow (FEF 25-75) is the mean forced expiratory flow during the middle half of the FVC.
Measured: Day 1 of treatment periods 1 to 5
Spirometry (FEF 25-75)
Lung function test: the forced mid-expiratory flow (FEF 25-75) is the mean forced expiratory flow during the middle half of the FVC.
Measured: Day 2 of treatment periods 1 to 5
Spirometry (FEF 25-75)
Lung function test: forced mid-expiratory flow (FEF 25-75) is the mean forced expiratory flow during the middle half of the FVC
Measured: Day 21 of treatment period 5.
Spirometry (FEV1/FVC)
Lung function test: FEV1 as a percentage of FVC (FEV1/FVC).
Measured: Day 1 of treatment periods 1 to 5.
Spirometry (FEV1/FVC)
Lung function test: FEV1 as a percentage of FVC (FEV1/FVC).
Measured: Day 2 of treatment periods 1 to 5.
Spirometry (FEV1/FVC)
Lung function test: FEV1 as a percentage of FVC (FEV1/FVC).
Measured: Day 21 of treatment period 5.
Impulse oscillometry (IOS) (R5, R5-R20)
Lung function test: A Jaeger impulse oscillometer will be used to obtain measurements according to the investigators standard operating procedure (SOP) and a published algorithm. The following settings will be used for IOS: oscillometric pressure impulses will be superimposed onto the tidal breathing of the subject, for about 30 s, with a pulse sequence of 5 per second and a frequency spectrum between 5 and 35 Hz. Resistance (R) at 5-20 Hz (R5 and R5-R20) during normal tidal breathing will be measured.
Measured: Change between baseline (day -1) and day 1 of treatment periods 1 to 5.
IOS (R5, R5-R20)
Lung function test: A Jaeger impulse oscillometer will be used to obtain measurements according to the investigators SOP and a published algorithm. The following settings will be used for IOS: oscillometric pressure impulses will be superimposed onto the tidal breathing of the subject, for about 30 s, with a pulse sequence of 5 per second and a frequency spectrum between 5 and 35 Hz. Resistance (R) at 5-20 Hz (R5 and R5-R20) during normal tidal breathing will be measured.
Measured: Day 21 of treatment period 5.
IOS (AX)
Lung function test: A Jaeger impulse oscillometer will be used to obtain measurements according to the investigators SOP and a published algorithm. The following settings will be used for IOS: oscillometric pressure impulses will be superimposed onto the tidal breathing of the subject, for about 30 s, with a pulse sequence of 5 per second and a frequency spectrum between 5 and 35 Hz. Reactance (X) at 5-20 Hz (AX) during normal tidal breathing will be measured.
Measured: Change between baseline (day -1) and day 1 of treatment periods 1 to 5.
IOS (AX)
Lung function test: A Jaeger impulse oscillometer will be used to obtain measurements according to the investigators SOP and a published algorithm. The following settings will be used for IOS: oscillometric pressure impulses will be superimposed onto the tidal breathing of the subject, for about 30 s, with a pulse sequence of 5 per second and a frequency spectrum between 5 and 35 Hz. Reactance (X) at 5-20 Hz (AX) during normal tidal breathing will be measured.
Measured: Day 21 of treatment period 5.
Airway nitric oxide (FeNO)
FeNO will be measured using the NIOX Viro handheld electronic device.
Measured: Change between baseline (day -1) and day 1 of treatment periods 1 to 5.
Airway nitric oxide (FeNO)
FeNO will be measured using the NIOX Viro handheld electronic device.
Measured: Day 21 of treatment period 5.
Blood eosinophils
Blood eosinophils concentration will be used as an inflammatory marker.
Measured: Day -1 of treatment periods 1 to 5.
Blood eosinophils
Blood eosinophils concentration will be used as an inflammatory marker.
Measured: Day 21 of treatment period 5.
Secondary outcomes (16)
Vital signs (safety): Blood pressure
Vital signs are assessed to determine safety and tolerability of treatment.
Measured: Day 1 and 2 of treatment periods 1 to 5. Day 21 and 22 of treatment periods 3 to 5.
Vital signs (safety): Heart rate
Vital signs are assessed to determine safety and tolerability of treatment.
Measured: Day 1 and 2 of treatment periods 1 to 5. Day 21 and 22 of treatment periods 3 to 5.
Vital signs (safety): Respiratory rate
Vital signs are assessed to determine safety and tolerability of treatment.
Measured: Day 1 and 2 of treatment periods 1 to 5. Day 21 and 22 of treatment periods 3 to 5.
Vital signs (safety): Oral temperature
Vital signs are assessed to determine safety and tolerability of treatment.
Measured: Day 1 and 2 of treatment periods 1 to 5. Day 21 and 22 of treatment periods 3 to 5.
Safety tests of blood and urine
Blood and urine for safety tests will be collected before dosing. Blood will be taken for haematology (2 mL in EDTA), and biochemistry and serology (2 x 3.5 mL).
Measured: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
12-lead ECG: Ventricular rate (safety)
12-lead ECG will be taken to assess safety and tolerability of treatment. Ventricular rate will be assessed.
Measured: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
12-lead ECG: PR interval (safety)
12-lead ECG will be taken to assess safety and tolerability of treatment. The PR interval is the time from the onset of the P wave to the start of the QRS complex.
Measured: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
12-lead ECG: QRS (safety)
12-lead ECG will be taken to assess safety and tolerability of treatment. The QRS complex is the combination of the Q, R and S waves.
Measured: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
12-lead ECG: QT interval (safety)
12-lead ECG will be taken to assess safety and tolerability of treatment. Corrected QT interval using the Frederica formula (QTcF).
Measured: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
ECG telemetry: Ventricular rate (safety)
The ECG will be monitored continuously from 30 min before until 24h after dosing, using a SpaceLabs system.
Measured: Day 1 of treatment periods 1 to 5.
ECG telemetry: PR interval (safety)
The ECG will be monitored continuously from 30 min before until 24h after dosing, using a SpaceLabs system.
Measured: Day 1 of treatment periods 1 to 5.
ECG telemetry: QRS (safety)
The ECG will be monitored continuously from 30 min before until 24h after dosing, using a SpaceLabs system.
Measured: Day 1 of treatment periods 1 to 5.
ECG telemetry: QT interval (safety)
The ECG will be monitored continuously from 30 min before until 24h after dosing, using a SpaceLabs system.
Measured: Day 1 of treatment periods 1 to 5.
Peak expiratory flow rate (PEFR)
Subjects will be given a PEFR meter. A drop of 20% of a subject's normal PEFR is considered in the normal range.
Measured: Day -1 to 6 for treatment periods 1 and 2. Day -1 to 7 and day 8 and 16 of treatment periods 3 to 5. Day 21 of treatment period 5.
FEV1 (safety)
Forced expiratory volume in 1 second.
Measured: Day -1 of treatment periods 1 to 5.
Pulse oximetry
Pulse oximetry is a non-invasive method for monitoring the saturation of oxygen in the peripheral blood, which will be measured using the SpaceLabs Patients Care Monitoring System (PCMS) and a standard HMR SOP.
Measured: Day 1 and 2 of treatment periods 1 to 5. Day 21 of treatment periods 3 to 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start28 Feb 2018
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Phase 1 trial is randomised, double-blind, placebo-controlled, and ascending-dose in design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trio Medicines Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Responsible party
- Sponsor
- Investigators
- Denisa Wilkes, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272135
- Sponsor's protocol ID
- T-030
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Ascending-dose Study to Assess the Safety, Tolerability and Efficacy of TR4, a Selective β2-adrenoceptor (β2-AR) Antagonist, in Patients With Mild-to-moderate Asthma
- ClinicalTrials.gov ID
- NCT07272135
- Acronym / sponsor ID
- T-030
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Trio Medicines Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives are to assess the safety, tolerability and effect on the airways of TR4 in patients with mild-to-moderate asthma. The Phase 1 trial is randomised, double-blind, placebo-controlled, and ascending-dose in design.
Detailed description
After a run-in period of 2 weeks, 12 eligible patients will be randomised to treatment with either TR4 or placebo. Nine patients will take incremental doses of 2.5, 5, 10 and 20 mg of TR4 capsules, each dose three times daily for 7 days, and then 40 mg three times daily for 21 days, over a total period of 7 weeks. Three patients will take matching placebo capsules in a similar manner.
The number of visits and the types are as follows. There will be a maximum of 10 visits to Hammersmith Medicines Research (HMR) for those subjects who complete the whole study according to the protocol. Visit 1 is an out-patient visit for informed consent and screening. Visit 2 is a short out-patient visit at the start of a 2-week run-in period for those subjects who pass screening. After the run-in period, patients who are still eligible will be given a schedule for 8 further visits (Visits 3-10). Participants will stay on the ward for 2 nights during 5 of those visits (Visits 3-7), and for 1 night during Visit 10. Visits 8 and 9 are short out-patient visits. The study will take each subject ~10 weeks to complete. For purposes of data collection and management the study is divided into one session for screening, a run-in period and 5 treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The Phase 1 trial is randomised, double-blind, placebo-controlled, and ascending-dose in design.
| Arm | Type | Receives |
|---|---|---|
| TR4 | Experimental | Drug: TR4After a run-in period of 2 weeks, 9 patients will be randomly assigned to the TR4 treatment arm. These 9 patients will take incremental doses of 2.5, 5, 10, and 20 mg of TR4, each dose three times daily for 7 days, and then 40 mg three times daily for 21 days, over a total period of 7 weeks. |
| Placebo | Placebo comparator | Other: PlaceboThree patients will take matching placebo capsules in a similar manner to TR4. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men or women
- Minimum 21 years old
- History of mild-to-moderate asthma for at least 6 months and controlled by an inhaled SABA, as required
- Otherwise healthy
- Ideally have participated in previous asthma studies
Key exclusion criteria (12 listed)
- Positive test for hepatitis B \& C or HIV
- Drug or alcohol abuse
- Airway infection or asthma exacerbation in the last 4 weeks
- Current seasonal asthma
- History of emergency treatment of asthma
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 |
|---|---|---|
| TR4TR4 is a selective beta-2-adrenoceptor antagonist. TR4 will be weighed into opaque capsules and released for individual patients, in accordance with good manufacturing practice (GMP). | Drug | TR4 |
| PlaceboPlacebo capsules will contain start in opaque capsules. | Other | Placebo |
Primary outcome
Mannitol (PD15)
Time frame: Baseline (day -1) of treatment periods 1 to 5.
The dose of mannitol causing a 15% fall in FEV1
Mannitol (PD15)
Time frame: Day 21 of treatment period 5.
The dose of mannitol causing a 15% fall in FEV1
Spirometry (FEV1)
Time frame: Day 1 of treatment periods 1 to 5.
Lung function test: The forced expiratory volume in 1 second (FEV1).
Spirometry (FEV1)
Time frame: Day 2 of treatment periods 1 to 5.
Lung function test: The forced expiratory volume in 1 second (FEV1).
Spirometry (FEV1)
Time frame: Day 21 of treatment period 5.
Lung function test: The forced expiratory volume in 1 second (FEV1).
Spirometry (FVC)
Time frame: Day 1 of treatment periods 1 to 5
Lung function test: forced vital capacity (FVC)
Spirometry (FVC)
Time frame: Day 2 of treatment periods 1 to 5
Lung function test: forced vital capacity (FVC).
Spirometry (FVC)
Time frame: Day 21 of treatment period 5
Lung function test: forced vital capacity (FVC).
Spirometry (FEF 25-75)
Time frame: Day 1 of treatment periods 1 to 5
Lung function test: forced mid-expiratory flow (FEF 25-75) is the mean forced expiratory flow during the middle half of the FVC.
Spirometry (FEF 25-75)
Time frame: Day 2 of treatment periods 1 to 5
Lung function test: the forced mid-expiratory flow (FEF 25-75) is the mean forced expiratory flow during the middle half of the FVC.
Spirometry (FEF 25-75)
Time frame: Day 21 of treatment period 5.
Lung function test: forced mid-expiratory flow (FEF 25-75) is the mean forced expiratory flow during the middle half of the FVC
Spirometry (FEV1/FVC)
Time frame: Day 1 of treatment periods 1 to 5.
Lung function test: FEV1 as a percentage of FVC (FEV1/FVC).
Spirometry (FEV1/FVC)
Time frame: Day 2 of treatment periods 1 to 5.
Lung function test: FEV1 as a percentage of FVC (FEV1/FVC).
Spirometry (FEV1/FVC)
Time frame: Day 21 of treatment period 5.
Lung function test: FEV1 as a percentage of FVC (FEV1/FVC).
Impulse oscillometry (IOS) (R5, R5-R20)
Time frame: Change between baseline (day -1) and day 1 of treatment periods 1 to 5.
Lung function test: A Jaeger impulse oscillometer will be used to obtain measurements according to the investigators standard operating procedure (SOP) and a published algorithm. The following settings will be used for IOS: oscillometric pressure impulses will be superimposed onto the tidal breathing of the subject, for about 30 s, with a pulse sequence of 5 per second and a frequency spectrum between 5 and 35 Hz. Resistance (R) at 5-20 Hz (R5 and R5-R20) during normal tidal breathing will be measured.
IOS (R5, R5-R20)
Time frame: Day 21 of treatment period 5.
Lung function test: A Jaeger impulse oscillometer will be used to obtain measurements according to the investigators SOP and a published algorithm. The following settings will be used for IOS: oscillometric pressure impulses will be superimposed onto the tidal breathing of the subject, for about 30 s, with a pulse sequence of 5 per second and a frequency spectrum between 5 and 35 Hz. Resistance (R) at 5-20 Hz (R5 and R5-R20) during normal tidal breathing will be measured.
IOS (AX)
Time frame: Change between baseline (day -1) and day 1 of treatment periods 1 to 5.
Lung function test: A Jaeger impulse oscillometer will be used to obtain measurements according to the investigators SOP and a published algorithm. The following settings will be used for IOS: oscillometric pressure impulses will be superimposed onto the tidal breathing of the subject, for about 30 s, with a pulse sequence of 5 per second and a frequency spectrum between 5 and 35 Hz. Reactance (X) at 5-20 Hz (AX) during normal tidal breathing will be measured.
IOS (AX)
Time frame: Day 21 of treatment period 5.
Lung function test: A Jaeger impulse oscillometer will be used to obtain measurements according to the investigators SOP and a published algorithm. The following settings will be used for IOS: oscillometric pressure impulses will be superimposed onto the tidal breathing of the subject, for about 30 s, with a pulse sequence of 5 per second and a frequency spectrum between 5 and 35 Hz. Reactance (X) at 5-20 Hz (AX) during normal tidal breathing will be measured.
Airway nitric oxide (FeNO)
Time frame: Change between baseline (day -1) and day 1 of treatment periods 1 to 5.
FeNO will be measured using the NIOX Viro handheld electronic device.
Airway nitric oxide (FeNO)
Time frame: Day 21 of treatment period 5.
FeNO will be measured using the NIOX Viro handheld electronic device.
Blood eosinophils
Time frame: Day -1 of treatment periods 1 to 5.
Blood eosinophils concentration will be used as an inflammatory marker.
Blood eosinophils
Time frame: Day 21 of treatment period 5.
Blood eosinophils concentration will be used as an inflammatory marker.
16 secondary outcomes
Vital signs (safety): Blood pressure
Time frame: Day 1 and 2 of treatment periods 1 to 5. Day 21 and 22 of treatment periods 3 to 5.
Vital signs (safety): Heart rate
Time frame: Day 1 and 2 of treatment periods 1 to 5. Day 21 and 22 of treatment periods 3 to 5.
Vital signs (safety): Respiratory rate
Time frame: Day 1 and 2 of treatment periods 1 to 5. Day 21 and 22 of treatment periods 3 to 5.
Vital signs (safety): Oral temperature
Time frame: Day 1 and 2 of treatment periods 1 to 5. Day 21 and 22 of treatment periods 3 to 5.
Safety tests of blood and urine
Time frame: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
12-lead ECG: Ventricular rate (safety)
Time frame: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
12-lead ECG: PR interval (safety)
Time frame: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
12-lead ECG: QRS (safety)
Time frame: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
12-lead ECG: QT interval (safety)
Time frame: Day 1 of treatment periods 1 to 5 and day 22 of treatment periods 3 to 5.
ECG telemetry: Ventricular rate (safety)
Time frame: Day 1 of treatment periods 1 to 5.
ECG telemetry: PR interval (safety)
Time frame: Day 1 of treatment periods 1 to 5.
ECG telemetry: QRS (safety)
Time frame: Day 1 of treatment periods 1 to 5.
ECG telemetry: QT interval (safety)
Time frame: Day 1 of treatment periods 1 to 5.
Peak expiratory flow rate (PEFR)
Time frame: Day -1 to 6 for treatment periods 1 and 2. Day -1 to 7 and day 8 and 16 of treatment periods 3 to 5. Day 21 of treatment period 5.
FEV1 (safety)
Time frame: Day -1 of treatment periods 1 to 5.
Pulse oximetry
Time frame: Day 1 and 2 of treatment periods 1 to 5. Day 21 of treatment periods 3 to 5.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Denisa Wilkes principal investigator
Hammersmith Medicines Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TR4 in people with Asthma, run by Trio Medicines Ltd. at 1 site 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 13 inclusion and 12 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mannitol (PD15) (time frame: Baseline (day -1) of treatment periods 1 to 5.). The study lists 22 primary outcomes in all. 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 9 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.