Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in 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

Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis (NCT07073638) is a Phase 2 interventional studying Pulmonary Tuberculoses, sponsored by Thirty Respiratory Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Pulmonary Tuberculoses and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Provide written, willing to sign a consent form prior to all trial-related procedures and agree to undergo all trial procedures. 2. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive. 3. Newly diagnosed pulmonary TB. 4. Rifampicin susceptible pulmonary TB as determined by molecular testing. 5. Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 mL or more). 6. Spirometry performed during screening with a Forced Expiration Volume in the first second (FEV1) of ≥ 40%. 7. Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4. Who Should NOT Join This Trial: 1. HIV positive AND CD4 \< 350 cells/mm3 OR are receiving antiviral therapy (ART) 2. Baseline Methaemoglobin saturation (SpMet) \>3%. 3. Female patients who is pregnant or breast-feeding. 4. 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. 5. Participation in other clinical studies with investigational agents within 8 weeks prior to screening. 6. Treatment received for this episode of TB with any drug active against M.tb 7. 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. 8. Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial procedures. 2. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive. 3. Newly diagnosed pulmonary TB. 4. Rifampicin susceptible pulmonary TB as determined by molecular testing. 5. Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 mL or more). 6. Spirometry performed during screening with a Forced Expiration Volume in the first second (FEV1) of ≥ 40%. 7. Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4. Exclusion Criteria: 1. HIV positive AND CD4 \< 350 cells/mm3 OR are receiving antiviral therapy (ART) 2. Baseline Methaemoglobin saturation (SpMet) \>3%. 3. Female patients who is pregnant or breast-feeding. 4. 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. 5. Participation in other clinical studies with investigational agents within 8 weeks prior to screening. 6. Treatment received for this episode of TB with any drug active against M.tb 7. 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. 8. Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening.

Treatments Being Tested

DRUG

RESP30TB

Nitric Oxide agent

DRUG

HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)

isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

TASK Clinical Research Centre

Cape Town, Bellville, South Africa

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07073638), the sponsor (Thirty Respiratory Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07073638 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07073638?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07073638?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07073638. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07073638. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.