Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Allergic Bronchopulmonary Aspergillosis
In brief
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
Key facts
- Study ID
- NCT03960606
- Run by
- Pulmatrix Inc.
- People needed
- 7
- Starts
- 2019-07-31
- Expected to finish
- 2020-07-14
- Last updated by the study team
- 2021-08-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Is a female of childbearing potential who is pregnant or lactating or who plans to become pregnant during the study. A woman is considered to be of childbearing potential unless she is either permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or postmenopausal (had no menses for 12 months without an alternative medical cause).
- Has a history of life-threatening asthma within the last 5 years, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures.
- Had an occurrence of asthma or ABPA exacerbations within the 28 days before screening or during the 28-day period before Day 1.
- Had an occurrence of clinically significant bacterial, viral, or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals, or antifungals within the 28 days before screening. Topical treatments, other than antifungals, are allowed.
- Received any investigational medical product in a clinical research study within the previous 3 months before dosing in this study.
- Has previously received PUR1900.
- Has a history of any significant drug or alcohol abuse in the past 2 years before screening, as judged by the investigator.
- Has current tobacco or inhaled marijuana use or history of smoking tobacco or marijuana within the last 6 months before screening.
- Is a current user of e-cigarettes or has used these products within the last 6 months before screening.
- Has a positive urine test result for drugs of abuse, alcohol, or cotinine at screening
- Has a history of allergies to or hypersensitivity reactions after dosing of itraconazole or other antifungal azoles.
- Had a major trauma or surgery within the last 28 days before screening.
Where it is running
- National Jewish Health — Denver, Colorado, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Integrity Clinical Research Center Inc. — Hialeah, Florida, United States
- Heuer M.D Research Inc. — Miami Lakes, Florida, United States
- Infinite Clinical Trials — Roswell, Georgia, United States
- University Consultants In Allergy and Immunology — Chicago, Illinois, United States
- Laporte County Institute for Clinical Research — Michigan City, Indiana, United States
- Montefiore Medical Center — The Bronx, New York, United States
- University of Texas Medical Branch at Galveston — Galveston, Texas, United States
- John Hunter Hospital — New Lambton, New South Wales, Australia
- Mater Private Hospital Brisbane — Brisbane, Queensland, Australia
- Yashoda Hospital — Hyderabad, Andhra Pradesh, India
- Shree Hospital And Critical Care Centre — Nagpur, Maharashtra, India
- SMS Medical College and Hospital — Jaipur, Rajasthan, India
- Centrum Alergologii Teresa Hofman — Poznan, Greater Poland Voivodeship, Poland
- Centrum Medycyny Oddechowej Mroz sp. j. — Bialystok, Podlaskie Voivodeship, Poland
- Uniwersyteckie Centrum Kliniczne - PPDS — Gdansk, Pomeranian Voivodeship, Poland
- PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C. — Sosnowiec, Silesian Voivodeship, Poland
- Birmingham Heartlands Hospital — Birmingham, West Midlands, United Kingdom
- Wythenshawe Hospital - PPDS — Manchester, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.