NCT05667662Phase 2Terminated

Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-02-27Actual

Enrollment · participants8Actual

Source updated2024-04-02Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

ABPA

Treatments or interventions studied

Itraconazole PowderDrugAlso known as PUR1900
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Incidence of Treatment Emergent Adverse Events (TEAEs); description: Review of TEAEs from time of consent to study completion.; timeFrame: 168 days; measure: Safety spirometry assessments; description: FEV1 (the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration), FVC (liters), and PEFR (L/min) measurements compared to baseline.; timeFrame: 168 days; measure: Vital sign measurements; description: Vital signs measurements collected before exposure, during and after treatment and compared to baseline. Vital sign measurements will include respiratory rate (bpm), blood pressure (mmHg), heart rate (bpm), oxygen saturation (by pulse oximetry), and oral or tympanic temperature (°C).; timeFrame: 168 days; measure: Physical examinations; description: At screening, a complete physical examination will be performed which includes measurement of height (cm), weight (kg) and evaluation of appearance; skin; head and neck; eyes, ears, nose, and throat; chest and lungs; heart; abdomen; neurological system; and extremities.; timeFrame: 168 Days; measure: Clinical safety laboratory test results; description: Hematology, serum chemistry, or urinalysis test results (normal, abnormal, clinical significance) compared to baseline.; timeFrame: 168 days; measure: Cardiac safety monitoring; description: Electrocardiogram (ECG) recordings collected before exposure, during and after treatment. Electrocardiogram measurements will include heart rate and PR, RR, QRS, and QT intervals, as well as the QTcF and compared to baseline.; timeFrame: 168 days

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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