A phase I study investigating local tolerability and pharmacokinetics of Isoniazid (INH) inhalation by wet nebulization in patients with tuberculosis

• Conditions: Tuberculosis; 10028440

• Registration Number: NL-OMON56472
• Lead Sponsor: Rijksuniversiteit Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 8

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 aluminum 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 fluorquinolone 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For the local tolerability, spirometry will be performed and adverse events<br /><br>will be recorded. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following serum pharmacokinetic parameters will be calculated: AUC0-24<br /><br>(area under the concentration-time curve 0-24 h post-administration), Cmax<br /><br>(maximum serum concentration), Tmax (time to maximum serum concentration). </p><br>