Pulmonary TuberculosesPhase 2NCT07073638
Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis
A Phase 2 study testing RESP30TB and HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination) in people with Pulmonary Tuberculoses, run by Thirty Respiratory Limited at 1 site in South Africa.
Trial summary
A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Tuberculoses
- What is being tested?
- RESP30TB and HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Africa
- Study dates
- 13 Oct 2025to 15 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial procedures.
- Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
- Newly diagnosed pulmonary TB.
- Rifampicin susceptible pulmonary TB as determined by molecular testing.
- Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 mL or more).
- Spirometry performed during screening with a Forced Expiration Volume in the first second (FEV1) of ≥ 40%.
- Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4.
Who cannot join
- HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART)
- Baseline Methaemoglobin saturation (SpMet) >3%.
- Female patients who is pregnant or breast-feeding.
- Patients planning to conceive a child within the anticipated period of trial participation and for at least 90 days after the last dose of IMP in the trial.
- Participation in other clinical studies with investigational agents within 8 weeks prior to screening.
- Treatment received for this episode of TB with any drug active against M.tb
- Treatment with immunosuppressive medications such as TNF-alpha inhibitors within 2 weeks prior to screening, or systemic corticosteroids for more than 7 days within 2 weeks prior to screening.
- Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
TASK Clinical Research Centre
Cape Town, Bellville, 7531
Lukhanyile Ketelo, +27 21 917 1044, l.ketelo@taskclinical.com
About this study
Official title: A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults With Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
Read the detailed description
This is a single-centre, open-label, single arm, clinical trial in two sequential stages, with no stratification. 12 patients will be enrolled in Stage 1, and a further 12 patients will be enrolled in Stage 2 (total of 24 patients in the trial).
- Conditions
- Pulmonary Tuberculoses
- Being tested
- RESP30TB, HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESP30TBDrug
Nitric Oxide agent
HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)Drug
isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
| Study group | Role | What they receive |
|---|---|---|
| RESP30TB | Experimental | Stage 1 - Inhaled RESP30TB 6ml via nebulisation three times daily Receives: Drug: RESP30TB |
| RESP30TB + HRZE | Experimental | Stage 2 - Inhaled RESP30TB 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily Receives: Drug: RESP30TB; Drug: HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death
Measured: Dosing period 14 days + Follow-up period 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start13 Oct 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosesStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thirty Respiratory Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073638
- Sponsor's protocol ID
- RESP30TB-EBA
- Status last verified
- Jan 2026
- First submitted
- 9 Jul 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is confidential until the CSR is published
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults With Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT07073638
- Acronym / sponsor ID
- RESP30TB-EBA
- Conditions
- Pulmonary Tuberculoses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Thirty Respiratory LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 18 Jul 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.
A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
Detailed description
This is a single-centre, open-label, single arm, clinical trial in two sequential stages, with no stratification. 12 patients will be enrolled in Stage 1, and a further 12 patients will be enrolled in Stage 2 (total of 24 patients in the trial).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESP30TB | Experimental | Drug: RESP30TBStage 1 - Inhaled RESP30TB 6ml via nebulisation three times daily |
| RESP30TB + HRZE | Experimental | Drug: RESP30TB, Drug: HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)Stage 2 - Inhaled RESP30TB 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial procedures.
- Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
- Newly diagnosed pulmonary TB.
- Rifampicin susceptible pulmonary TB as determined by molecular testing.
- Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 mL or more).
Key exclusion criteria (8 listed)
- HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART)
- Baseline Methaemoglobin saturation (SpMet) >3%.
- Female patients who is pregnant or breast-feeding.
- Patients planning to conceive a child within the anticipated period of trial participation and for at least 90 days after the last dose of IMP in the trial.
- Participation in other clinical studies with investigational agents within 8 weeks prior to screening.
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 |
|---|---|---|
| RESP30TBNitric Oxide agent | Drug | RESP30TB, RESP30TB + HRZE |
| HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E) | Drug | RESP30TB + HRZE |
Primary outcome
Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Dosing period 14 days + Follow-up period 14 days
Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. IPD is confidential until the CSR is published
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RESP30TB and HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination) in people with Pulmonary Tuberculoses, run by Thirty Respiratory Limited at 1 site in South Africa.
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 7 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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 South Africa. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs) (time frame: Dosing period 14 days + Follow-up period 14 days). 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 12 Jan 2026.