Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
Rifampicin Susceptible Pulmonary Tuberculosis
![Thirty Respiratory Limited](https://trials-media.s3.amazonaws.com/orgs/thirty-respiratory-limited.jpeg)
About this trial
This is an interventional treatment trial for Rifampicin Susceptible Pulmonary Tuberculosis focused on measuring Early Bactericidal Activity (EBA)
Eligibility Criteria
Inclusion Criteria: Provide written, informed consent prior to all study-related procedures and agree to undergo all study 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 FEV1 of ≥ 40% Be of non-childbearing potential or willing to use effective methods of contraception Exclusion Criteria: HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART) Methaemoglobin saturation (SpMet) >3% Female participant who is pregnant or breast-feeding Participants planning to conceive a child within the anticipated period of study participation and for at least 90 days after the last dose of IMP in the study 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 nitric oxide and other nitric oxide donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening
Sites / Locations
- TASK Clinical Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Experimental
Experimental
Experimental
1 (Active)
2 (Control)
3 (Active)
4 (Active)
5 (Active)
Inhaled RESP301 6ml via nebulisation three times daily
HRZE taken orally once daily
Inhaled RESP301 6 ml via nebulisation once daily
Inhaled RESP301 6 ml via nebulisation twice daily
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once dialy