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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03960606




Registration number
NCT03960606
Ethics application status
Date submitted
14/05/2019
Date registered
23/05/2019

Titles & IDs
Public title
Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis
Scientific 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
Secondary ID [1] 0 0
601-0014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Bronchopulmonary Aspergillosis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - PUR1900
Other interventions - Placebo

Experimental: 10 mg PUR1900 - Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler)

Experimental: 20 mg PUR1900 - Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler)

Experimental: 35 mg PUR1900 - Study drug (PUR1900) will be administered orally, using a Dry Powder Inhaler (DPI) specific to the study (RS01 Monodose inhaler)

Placebo comparator: Placebo - Placebo


Other interventions: PUR1900
PUR1900 contains itraconazole as the active ingredient, and it is formulated as a dry powder for oral inhalation.

Other interventions: Placebo
PUR1900 placebo
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events
Timepoint [1] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Primary outcome [2] 0 0
Incidence of intraday FEV1 declines
Timepoint [2] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Primary outcome [3] 0 0
Respiratory rate
Timepoint [3] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Primary outcome [4] 0 0
Blood pressure
Timepoint [4] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Primary outcome [5] 0 0
Heart rate
Timepoint [5] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Primary outcome [6] 0 0
Oxygen saturation
Timepoint [6] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Primary outcome [7] 0 0
Physical examination findings
Timepoint [7] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Primary outcome [8] 0 0
Clinical laboratory test results
Timepoint [8] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Primary outcome [9] 0 0
12-Lead electrocardiogram findings
Timepoint [9] 0 0
From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
Secondary outcome [1] 0 0
Sputum concentrations of itraconazole and hydroxy-itraconazole
Timepoint [1] 0 0
Day 2 to Day 28
Secondary outcome [2] 0 0
Sputum eosinophils
Timepoint [2] 0 0
(Day -9 to Day -6) to Day 28
Secondary outcome [3] 0 0
To evaluate the effect of PUR1900 on pulmonary function following single- and multiple-dose administration of PUR1900
Timepoint [3] 0 0
Day 1 to Day 28
Secondary outcome [4] 0 0
Asthma Control Questionnaire-6 (ACQ 6)
Timepoint [4] 0 0
Day 1 to Day 28
Secondary outcome [5] 0 0
Change from baseline (Day 1) to Day 28 in A fumigatus burden in sputum
Timepoint [5] 0 0
Day 1 to Day 28
Secondary outcome [6] 0 0
Cmax (maximum observed concentration in plasma)
Timepoint [6] 0 0
Day 1 to Day 28
Secondary outcome [7] 0 0
Tmax (time to maximum concentration in plasma)
Timepoint [7] 0 0
Day 1 to Day 28
Secondary outcome [8] 0 0
AUC (area under the concentration-time curve)
Timepoint [8] 0 0
Day 1 to Day 28
Secondary outcome [9] 0 0
CL/F (clearance)
Timepoint [9] 0 0
Day 1 to Day 28
Secondary outcome [10] 0 0
Vz/F (apparent volume of distribution)
Timepoint [10] 0 0
Day 1 to Day 28

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/07/2020
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 0 0
Mater Private Hospital Brisbane - Brisbane
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
India
State/province [9] 0 0
Andhra Pradesh
Country [10] 0 0
India
State/province [10] 0 0
Maharashtra
Country [11] 0 0
India
State/province [11] 0 0
Rajasthan
Country [12] 0 0
Poland
State/province [12] 0 0
Podlaskie
Country [13] 0 0
Poland
State/province [13] 0 0
Pomorskie
Country [14] 0 0
Poland
State/province [14] 0 0
Slaskie
Country [15] 0 0
Poland
State/province [15] 0 0
Wielkopolskie
Country [16] 0 0
United Kingdom
State/province [16] 0 0
West Midlands
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pulmatrix Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William J. Calhoun, MD
Address 0 0
University of Texas Medical Branch Galveston, TX 77555
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03960606