Isoniazid inhalation in TB patients: a first-in-human look at local tolerability and body levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study investigates the local tolerability and pharmacokinetics of inhaled isoniazid delivered by wet nebulization in adults with pulmonary TB. Participants must have drug-susceptible or -resistant TB, be clinically stable on TB therapy, and not have pregnancy or certain drug interactions. The trial assesses safety and how the drug distributes and clears when given directly to the lungs, which may yield high local drug levels with potentially lower systemic exposure. Exclusion criteria include poor lung function, recent adverse reactions to isoniazid, certain concurrent medications, and conditions increasing cardiac risk. The study is sponsored by University Medical Center Groningen with no listed collaborators and will occur at the same institution in Groningen, Netherlands.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years and older
* Diagnosis of TB with known drug susceptibility, either by culture or molecular testing
* Clinically stable or improving after at least 2 weeks of effective TB treatment
* Obtained written informed consent

Exclusion Criteria:

* Patients that are pregnant, or breast feeding
* History of adverse events on previous or current INH use
* FEV1 \< 30% predicted
* Concurrent use of corticosteroids in varying dose (a stable dose one week before participating and during the study is allowed).
* Concurrent use of aluminium containing medicines (i.e. antacids)
* Concurrent use of carbamazepine, phenytoin or theophylline

Additionally, a potential subject with DS-TB (eliciting switch to levofloxacin) who meets any of the following criteria will be excluded from participation in this study:

* History of epilepsy
* History of adverse events on previous levofloxacin or other fluoroquinolone use
* Risk of QTc prolongation (prolonged QTc-interval (\>450 msec), long-QT syndrome (LQTS) or concurrent use of high risk QTc prolongating drugs (amiodarone, erythromycin (daily dose \> 1000 mg) or sotalol)

Where it's running

• University Medical Center Groningen
  Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Cynthia Maharani, MD
• Email: c.maharani@umcg.nl
• Phone: +31503616161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.