Safety assessment of inhaled RESP301 in patients with pulmonary tuberculosis

Phase 2

Completed

• Conditions: Fully sensitive multidrug-resistant tuberculosis; Infections and Infestations; Tuberculosis

• Registration Number: ISRCTN14833199
• Lead Sponsor: Thirty Respiratory Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-30
• Study Completion: 2023-12-31
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Hospitalised patients with:
1. Smear, culture or DNA probe-proven pulmonary tuberculosis
2. On approved guideline-based treatment (subject to drug sensitivity)
3. Age =18 years of age
4. Able to give written informed consent
5. Able to understand instructions
6. Able to operate and maintain nebuliser, as assessed by the Investigator

Exclusion Criteria

1. Concomitant severe respiratory disease such as severe asthma and severe COPD with predicted FEV1 <40%
2. Any current or previous condition/circumstance that, in the opinion of the investigator, may put the individual at risk
3. Unable to tolerate the use of a nebuliser for approximately 8-10 minutes as required by the study, according to the Investigator’s opinion
4. Any unstable, uncontrolled, or severe medical condition that in the opinion of the investigator would make the participant unsuitable for the trial
5. Participation in other clinical investigations utilising investigational treatment within the last 30 days / 5 half-lives, whichever is longer
6. Known allergy/hypersensitivity to, or relevant drug-drug interaction with, the study drug/components of the study drug
7. History of methaemoglobinaemia
8. Any subject who in the opinion of the investigator would not be best served by participating in this clinical trial
9. Prescribed nitric oxide donating agents (e.g. nitroprusside, isosorbide dinitrate, isosorbide mononitrate, naproxcinod, molsidomine and linsidomine)

Study & Design

• Study Type: Interventional
• Study Design: Not specified