Inclusion
How many months is required on chest x-ray or CT scan for evidence of underlying nodular bronchiectasis and/or fibrocavitary disease?
True or False? Patients with a hx of treated latent or active TB may be eligible as long as their sputum cultures in the last year are negative for TB and they do not have current active TB.
True
What is the name of the drug we are studying?
Clofazimine Inhalation Suspension
What are the doses of study drug used in the study?
80mg/50mg
Medrio will be utilized for which two study related activities?
eCRF and PRO administration
The participant must be able to produce how many mls of sputum for mycobacteriology?
3 mL
How long should the participant wash out of clofazimine to participant in study?
Prior therapy with clofazimine in the previous 4 months from date of screening
What is the first procedure to occur at every visit on the the consent form has been signed?
QOLB and then remaining PROs
If a participant is not able to tolerate their dose are they allowed to down titrate to a lower dose?
Yes, 50 mg.
ALMAC IRT will dispense initial shipment of IP to a site at which recorded study visit?
V1-Screening
How many months must the participant be receiving GBT therapy to be included in study?
At least 6 months prior to consenting to participate in this study, with no changes in this regimen within 2 months of screening
Can a participant be included if using amikacin since it is an exclusion criteria?
Prior therapy with amikacin by any route of administration (e.g., inhaled or IV) in the previous 2 months from date of screening.
What happens with subject ID when is participant re-screens?
After a dose reduction, when could a participant be reintroduced to the higher dose?
After a dose reduction to 50 mg, the dose of Clofazimine Inhalation Suspension may not be re-increased to 80 mg in the same treatment cycle. The study participant may be restarted on the 80 mg dose at the beginning of the next treatment cycle.
Intelsius shipping boxes are used for shipment of sputum specimens to which vendor?
NJH-sputum lab
What percentage of FEV1 is required at screening via local spirometry to be included in the study?
FEV1 ≥40% of predicted
Participants cannot have used bedaquiline within how long to be included in study?
Correct, any prior use of bedaquiline within 1 year of screening
Which questionnaire is not a facing patient questionnaire?
Site questionnaire
How many times can a participant have a dose reduction in study?
Two
True or False? Ancillary supply kits are automatically shipped to sites for each planned cycle of participant dosing?
False. PARI ancillary supplies must be proactively reordered by the site prior to a participants next anticipated cycle starting. Multiple kits can be ordered at one time for efficiency.
There are two time periods related to MAC-positive culture results to be included in study – can you name at least 1?
Participant has to have at least two separate sputums (at least 1 week apart) expectorated, one taken within 12 months, and another taken within 3 months prior to the date of informed consent.
True or False? QT prolongation during screening (450 ms or longer), and/or uncontrolled sinus rhythm (>110/minute) can be included in the study.
False
What are the study co-primary endpoints?
Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for NTM) by the end of Month 6 and Change in QoL-B RSS from baseline to the end of Month 6
What happens if participant has to reduce to 50mg for the second time?
The participant will be allowed to reduce to 50 mg again, but they will not be allowed to re-increase to 80 mg for the rest of the study duration.
True or False? The ACM lab kit inventory resupply is automated?
False. Sites will need to keep a check on lab kit inventories and make proactive orders based on enrollment and participant progression through the study.