TerminatedPhase 2

Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis

Stopped: COVID-19 Pandemic

United States, Australia, India7 participantsStarted 2019-07-31

Plain-language summary

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Is a male or female, 18 to 75 years old (inclusive) at the time of signing the informed consent. * Has a body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening. * Has a historical diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update. * Has a confirmed historical diagnosis of ABPA, as per the Modified International Society for Human and Animal Mycology (ISHAM) working group 2013 criteria. * Is currently considered to be in one of the following stages of ABPA: Stage 2 (Response), Stage 4 (Remission), Stage 5a (Treatment-dependent ABPA), or Stage 5b (Glucocorticoid-dependent asthma) * Has a serum immunoglobulin (Ig) E ≥1000 IU/mL during screening (Visit 1 or Visit 2). * Can perform a valid, reproducible spirometry test with demonstration of a prebronchodilator FEV1 ≥50% of predicted normal for age, sex, race, and height (Quanjer et al 2012) at a screening visit. * Has a documented stable asthma medication regimen during screening (Day 28 to Day 1), including SABA, LABA, and LTRA use and inhaled and/or oral GCS. * Subjects who are sexually active, male subjects able to father a child, and female subjects of childbearing potential must agree to follow the contraception requirements of this protocol. * Can demonstrate the correct inhalation technique for the use of the delivery device at screening and before dosing. Exclusion Criteria: * Is a female of childbearing potential who is pregnant or lactating or who plans to bec…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of treatment-emergent adverse events

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Incidence of intraday FEV1 declines

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Respiratory rate

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Blood pressure

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Heart rate

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Oxygen saturation

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Physical examination findings

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Trial details

NCT IDNCT03960606

SponsorPulmatrix Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-14

View on ClinicalTrials.gov More Allergic Bronchopulmonary Aspergillosis trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of treatment-emergent adverse events

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Incidence of intraday FEV1 declines

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Respiratory rate

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Blood pressure

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Heart rate

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Oxygen saturation

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)

Physical examination findings

Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)