- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01785927
The Safety of Tuberculosis Treatments by Oral Inhalation
Clinical Trial Phase I of Antituberculosis Dry Powder Aerosols
The inhaled route of delivery has always been associated with the considerable challenge of getting the drug to its target. The lungs are a highly complex organ designed to filter inspired air, with many different cell types contributing to their function. Furthermore, the lungs may change dramatically when afflicted by disease resulting in an internal environment that works against the drug reaching and interacting successfully with the target. For targets in the upper airways this will have lesser significance, but drug delivery to the deep lung may be impeded by changes such as mucus hyper-secretion or thickening or airway narrowing.
In order to interpret toxicology findings it is necessary to reconcile test sensitivity, background biological variation, normal responses to inhaled materials and drug or medicine-specific adverse effects. Identification of adverse end-points is an area where better control data sets might help discern true adverse effects from a normal physiological lung response. The lung responds acutely to inhalation of irritant materials by hyper-secretion of mucus, chemokine release, inflammatory cell recruitment and cough and collectively these may be characterized as non-specific irritancy.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Teerapol Srichana, PhD
- Phone Number: 66-74-288979
- Email: teerapol.s@psu.ac.th
Study Locations
-
-
Songkla
-
Hat Yai, Songkla, Thailand, 90112
- Songklanagarind Hospital
-
Contact:
- Siwasak Juthong, MD
- Phone Number: 66-74-451474
- Email: jsiwasak@medicine.psu.ac.th
-
Sub-Investigator:
- Siwasak Juthong, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-45 years
- Body mass index 18-27 kg/m2
- Healthy
- In the case of reproductive age woman, effective contraceptive will be used for at least 4 weeks prior to a screening examination until the end of study.
- Non-lactating women
- Patients who are willing to participate in the trial and will first sign the informed consent form.
Exclusion Criteria:
- Allergic to any antituberculosis drugs or other components
- High blood pressure (diastolic pressure > 90 mmHg)
- Liver enzymes (AST and ALT) > 2 times of upper normal value
- Pregnancy or lactation
- No underlying diseases such as asthma, COPD, chronic kidney disease, diabetes mellitus, liver disease, immunocompromised deficiency, etc.
- HBsAg positive
- Abnormality in chest X-ray or routine laboratory tests
- Smokers > 10 cigarette/day or smokers < 10 cigarettes/day who could not quit at least 7 days before study and throughout study (including the washout between periods)
- Regular alcohol consumption (more than 1 time/week) or alcohol consumption within 7 days prior to the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ABCD
ABCD A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin
|
Rifampicin, isoniazid, pyrazinamide, and levofloxacin dry powders will be administered to each patient by randomization.
Each formulation will be assigned the code, such as A, B, C, or D, and the treatment sequences will be generated as ABCD (sequence 1), BCDA (sequence 2), CDAB (sequence 3) and DABC (sequence 4).
On the first day of drug dosing in period I, volunteers will be randomly assigned to a sequence of treatments as indicated in a pre-printed randomization scheme, which was generated using block randomization with block sizes of 4 and 6, and the allocation ratio of 1:1.
Subjects will be stratified by sex.
Subjects in sequence 1 will receive treatment A during the first study period and will then cross over to receive treatment B, C, and D at the second, third and fourth periods, respectively (each after a 7-day washout period).
|
Other: BCDA
BCDA A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin
|
Rifampicin, isoniazid, pyrazinamide, and levofloxacin dry powders will be administered to each patient by randomization.
Each formulation will be assigned the code, such as A, B, C, or D, and the treatment sequences will be generated as ABCD (sequence 1), BCDA (sequence 2), CDAB (sequence 3) and DABC (sequence 4).
On the first day of drug dosing in period I, volunteers will be randomly assigned to a sequence of treatments as indicated in a pre-printed randomization scheme, which was generated using block randomization with block sizes of 4 and 6, and the allocation ratio of 1:1.
Subjects will be stratified by sex.
Subjects in sequence 1 will receive treatment A during the first study period and will then cross over to receive treatment B, C, and D at the second, third and fourth periods, respectively (each after a 7-day washout period).
|
Other: CDAB
CDAB A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin
|
Rifampicin, isoniazid, pyrazinamide, and levofloxacin dry powders will be administered to each patient by randomization.
Each formulation will be assigned the code, such as A, B, C, or D, and the treatment sequences will be generated as ABCD (sequence 1), BCDA (sequence 2), CDAB (sequence 3) and DABC (sequence 4).
On the first day of drug dosing in period I, volunteers will be randomly assigned to a sequence of treatments as indicated in a pre-printed randomization scheme, which was generated using block randomization with block sizes of 4 and 6, and the allocation ratio of 1:1.
Subjects will be stratified by sex.
Subjects in sequence 1 will receive treatment A during the first study period and will then cross over to receive treatment B, C, and D at the second, third and fourth periods, respectively (each after a 7-day washout period).
|
Other: DABC
DABC A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin
|
Rifampicin, isoniazid, pyrazinamide, and levofloxacin dry powders will be administered to each patient by randomization.
Each formulation will be assigned the code, such as A, B, C, or D, and the treatment sequences will be generated as ABCD (sequence 1), BCDA (sequence 2), CDAB (sequence 3) and DABC (sequence 4).
On the first day of drug dosing in period I, volunteers will be randomly assigned to a sequence of treatments as indicated in a pre-printed randomization scheme, which was generated using block randomization with block sizes of 4 and 6, and the allocation ratio of 1:1.
Subjects will be stratified by sex.
Subjects in sequence 1 will receive treatment A during the first study period and will then cross over to receive treatment B, C, and D at the second, third and fourth periods, respectively (each after a 7-day washout period).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cytokine levels (Tumor Necrosis Factor-α and Interleukin-1β)
Time Frame: Two months
|
Two months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Liver function tests (tB/dB, AST, ALT, ALP)
Time Frame: Two months
|
Two months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: Two months
|
Two months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RES.no. 18/2554
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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