Pulmonary Tuberculoses
Conditions
Brief 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
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).
Interventions
DRUGRESP30TB
Nitric Oxide agent
isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
Sponsors
Thirty Respiratory Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs) | 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 |
Countries
South Africa
Outcome results
None listed