Allergic Bronchopulmonary AspergillosisPhase 2NCT03960606
Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis
A Phase 2 study testing PUR1900 in people with Allergic Bronchopulmonary Aspergillosis, run by Pulmatrix Inc. at 20 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis
- What is being tested?
- PUR1900
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 31 Jul 2019to 14 Jul 2020
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United States9 sites
University Consultants In Allergy and Immunology
Chicago, Illinois, 60612
National Jewish Health
Denver, Colorado, 80206
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Integrity Clinical Research Center Inc.
Hialeah, Florida, 33015
Heuer M.D Research Inc.
Miami Lakes, Florida, 32819
Laporte County Institute for Clinical Research
Michigan City, Indiana, 46360
Yale University School of Medicine
New Haven, Connecticut, 06520
Infinite Clinical Trials
Roswell, Georgia, 30076
Montefiore Medical Center
The Bronx, New York, 10461
Poland4 sites
Centrum Medycyny Oddechowej Mroz sp. j.
Bialystok, Podlaskie Voivodeship, 15-044
Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk, Pomeranian Voivodeship, 80-952
Centrum Alergologii Teresa Hofman
Poznan, Greater Poland Voivodeship, 60-214
PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.
Sosnowiec, Silesian Voivodeship, 41-200
India3 sites
Yashoda Hospital
Hyderabad, Andhra Pradesh, 500082
SMS Medical College and Hospital
Jaipur, Rajasthan, 302016
Shree Hospital And Critical Care Centre
Nagpur, Maharashtra, 440009
Australia2 sites
Mater Private Hospital Brisbane
Brisbane, Queensland, 4101
John Hunter Hospital
New Lambton, New South Wales, 2305
United Kingdom2 sites
Birmingham Heartlands Hospital
Birmingham, West Midlands, B9 5SS
Wythenshawe Hospital - PPDS
Manchester, M23 9LT
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, & Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Asthmatic Patients With ABPA
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
Read the detailed description
This is a randomized, double-blind, multicenter, placebo controlled, multiple-arm study.
Following screening and confirmation of eligibility, subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via dry powder inhalation daily for 28 days. The doses of PUR1900 are stated in this protocol as the respective nominal doses of itraconazole.
Subject eligibility for the study will be determined within 28 days before the first dose of study drug (Day 1) and will be confirmed between 9 and 6 days before dosing and again on Day 1.
Eligible subjects will begin daily dosing with study drug (PUR1900 or placebo) on Day 1.
Subjects will return to the study site for visits on Days 2, 7, 14, and 28 and will be dosed at the study site. The remaining daily doses of study drug will be self-administered at home.
A follow-up visit will occur 7 to 10 days after the last dose of study drug.
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Being tested
- PUR1900, Placebo
- Keywords
- Aspergillosis
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary, Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUR1900Combination product
PUR1900 contains itraconazole as the active ingredient, and it is formulated as a dry powder for oral inhalation.
PlaceboCombination product
PUR1900 placebo
| Study group | Role | What they receive |
|---|---|---|
| 10 mg PUR1900 | Experimental | Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler) Receives: Combination Product: PUR1900 |
| 20 mg PUR1900 | Experimental | Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler) Receives: Combination Product: PUR1900 |
| 35 mg PUR1900 | Experimental | Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler) Receives: Combination Product: PUR1900 |
| Placebo | Placebo comparator | Placebo Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Incidence of intraday FEV1 declines
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Respiratory rate
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Blood pressure
Systolic pressure over diastolic pressure
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Heart rate
Beats per minute
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Oxygen saturation
As a percentage
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Physical examination findings
Physician's notes
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Clinical laboratory test results
Lab reports with any out of range results flagged
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
12-Lead electrocardiogram findings
ECG report and tracing
Measured: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Secondary outcomes (10)
Sputum concentrations of itraconazole and hydroxy-itraconazole
Measured: Day 2 to Day 28
Sputum eosinophils
Measured: (Day -9 to Day -6) to Day 28
To evaluate the effect of PUR1900 on pulmonary function following single- and multiple-dose administration of PUR1900
Measured: Day 1 to Day 28
Asthma Control Questionnaire-6 (ACQ 6)
Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Measured: Day 1 to Day 28
Change from baseline (Day 1) to Day 28 in A fumigatus burden in sputum
As assessed by quantitative PCR and sputum culture
Measured: Day 1 to Day 28
Cmax (maximum observed concentration in plasma)
Measured: Day 1 to Day 28
Tmax (time to maximum concentration in plasma)
Measured: Day 1 to Day 28
AUC (area under the concentration-time curve)
Measured: Day 1 to Day 28
CL/F (clearance)
Measured: Day 1 to Day 28
Vz/F (apparent volume of distribution)
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start31 Jul 2019
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Bronchopulmonary AspergillosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following screening and confirmation of eligibility, subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via dry powder inhalation daily for 28 days.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William J. Calhoun, MD, Principal investigator, University of Texas Medical Branch Galveston, TX 77555David Denning, FRCP, FRC Path, FIDSA, FMedSci, Principal investigator, Director, National Aspergillosis Centre Manchester, Wythenshawe M23 9LT, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960606
- Sponsor's protocol ID
- 601-0014
- Status last verified
- Jul 2021
- First submitted
- 14 May 2019
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, & Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Asthmatic Patients With ABPA
- ClinicalTrials.gov ID
- NCT03960606
- Acronym / sponsor ID
- 601-0014
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Keywords
- Aspergillosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 23 May 2019 (actual)
- 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.
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
Detailed description
This is a randomized, double-blind, multicenter, placebo controlled, multiple-arm study.
Following screening and confirmation of eligibility, subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via dry powder inhalation daily for 28 days. The doses of PUR1900 are stated in this protocol as the respective nominal doses of itraconazole.
Subject eligibility for the study will be determined within 28 days before the first dose of study drug (Day 1) and will be confirmed between 9 and 6 days before dosing and again on Day 1.
Eligible subjects will begin daily dosing with study drug (PUR1900 or placebo) on Day 1.
Subjects will return to the study site for visits on Days 2, 7, 14, and 28 and will be dosed at the study site. The remaining daily doses of study drug will be self-administered at home.
A follow-up visit will occur 7 to 10 days after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Following screening and confirmation of eligibility, subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via dry powder inhalation daily for 28 days.
| Arm | Type | Receives |
|---|---|---|
| 10 mg PUR1900 | Experimental | Combination Product: PUR1900Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler) |
| 20 mg PUR1900 | Experimental | Combination Product: PUR1900Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler) |
| 35 mg PUR1900 | Experimental | Combination Product: PUR1900Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler) |
| Placebo | Placebo comparator | Combination Product: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| PUR1900PUR1900 contains itraconazole as the active ingredient, and it is formulated as a dry powder for oral inhalation. | Combination product | 10 mg PUR1900, 20 mg PUR1900, 35 mg PUR1900 |
| PlaceboPUR1900 placebo | Combination product | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Incidence of intraday FEV1 declines
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Respiratory rate
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Blood pressure
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Systolic pressure over diastolic pressure
Heart rate
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Beats per minute
Oxygen saturation
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
As a percentage
Physical examination findings
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Physician's notes
Clinical laboratory test results
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Lab reports with any out of range results flagged
12-Lead electrocardiogram findings
Time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
ECG report and tracing
10 secondary outcomes
Sputum concentrations of itraconazole and hydroxy-itraconazole
Time frame: Day 2 to Day 28
Sputum eosinophils
Time frame: (Day -9 to Day -6) to Day 28
To evaluate the effect of PUR1900 on pulmonary function following single- and multiple-dose administration of PUR1900
Time frame: Day 1 to Day 28
Asthma Control Questionnaire-6 (ACQ 6)
Time frame: Day 1 to Day 28
Change from baseline (Day 1) to Day 28 in A fumigatus burden in sputum
Time frame: Day 1 to Day 28
Cmax (maximum observed concentration in plasma)
Time frame: Day 1 to Day 28
Tmax (time to maximum concentration in plasma)
Time frame: Day 1 to Day 28
AUC (area under the concentration-time curve)
Time frame: Day 1 to Day 28
CL/F (clearance)
Time frame: Day 1 to Day 28
Vz/F (apparent volume of distribution)
Time frame: Day 1 to Day 28
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Allergic Bronchopulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingObservational study
T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Real-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis
Allergic Bronchopulmonary Aspergillosis, Severe Asthma
RecruitingObservational study
ML-Based ABPA Recurrence Prediction and Clinical Utility
ABPA, Allergic Bronchopulmonary Aspergillosis
RecruitingObservational study
Fungal Status and Prognosis in ABPA
ABPA, Allergic Bronchopulmonary Aspergillosis
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.
William J. Calhoun, MD principal investigator
University of Texas Medical Branch Galveston, TX 77555
David Denning, FRCP, FRC Path, FIDSA, FMedSci principal investigator
Director, National Aspergillosis Centre Manchester, Wythenshawe M23 9LT, UK
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PUR1900 in people with Allergic Bronchopulmonary Aspergillosis, run by Pulmatrix Inc. at 20 sites in 5 countries.
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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Poland, India, Australia, United Kingdom. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)). The study lists 9 primary outcomes in all. 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 27 Aug 2021.