HealthyPhase 1NCT01785927
The Safety of Tuberculosis Treatments by Oral Inhalation
A Phase 1 study testing ABCD in people with Healthy, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABCD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2013to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Songklanagarind Hospital
Hat Yai, Changwat Songkhla, 90112
Siwasak Juthong, MD, 66-74-451474, jsiwasak@medicine.psu.ac.th
Siwasak Juthong, MD
About this study
Official title: 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.
Read the detailed description
Four formulations of antituberculosis drug (rifampicin, isoniazid, pyrazinamide, and levofloxacin) 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).
- Conditions
- Healthy
- Being tested
- ABCD
- Keywords
- Antituberculosis, Dry powder aerosols, Inhalation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABCDOther
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).
| Study group | Role | What they receive |
|---|---|---|
| ABCD | Other | ABCD A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin Receives: Other: ABCD |
| BCDA | Other | BCDA A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin Receives: Other: ABCD |
| CDAB | Other | CDAB A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin Receives: Other: ABCD |
| DABC | Other | DABC A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin Receives: Other: ABCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine levels (Tumor Necrosis Factor-α and Interleukin-1β)
Measured: Two months
Secondary outcomes (1)
Liver function tests (tB/dB, AST, ALT, ALP)
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Principal investigator, Teerapol Srichana, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785927
- Sponsor's protocol ID
- RES.no. 18/2554
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Phase I of Antituberculosis Dry Powder Aerosols
- ClinicalTrials.gov ID
- NCT01785927
- Acronym / sponsor ID
- RES.no. 18/2554
- Conditions
- Healthy
- Keywords
- Antituberculosis, Dry powder aerosols, Inhalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Four formulations of antituberculosis drug (rifampicin, isoniazid, pyrazinamide, and levofloxacin) 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABCD | Other | Other: ABCDABCD A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin |
| BCDA | Other | Other: ABCDBCDA A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin |
| CDAB | Other | Other: ABCDCDAB A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin |
| DABC | Other | Other: ABCDDABC A = rifampicin, B = isoniazid, C= pyrazinamide, D = levofloxacin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABCDRifampicin, 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 | ABCD, BCDA, CDAB, DABC |
Primary outcome
Cytokine levels (Tumor Necrosis Factor-α and Interleukin-1β)
Time frame: Two months
1 secondary outcome
Liver function tests (tB/dB, AST, ALT, ALP)
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABCD in people with Healthy, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teerapol Srichana, PhD (66-74-288979, teerapol.s@psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine levels (Tumor Necrosis Factor-α and Interleukin-1β) (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.