Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis (NCT03960606) | Clinical Trial Compass
TerminatedPhase 2
Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis
Stopped: COVID-19 Pandemic
United States7 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 range18 Years – 75 Years
SexALL
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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…
What they're measuring
1
Incidence of treatment-emergent adverse events
Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
2
Incidence of intraday FEV1 declines
Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
3
Respiratory rate
Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
4
Blood pressure
Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
5
Heart rate
Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
6
Oxygen saturation
Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
7
Physical examination findings
Timeframe: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)