A Phase 1 interventional study of Itraconazole Powder and Itraconazole 200 mg in Asthma, sponsored by Pulmatrix Inc.. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-27.
Sponsored by Pulmatrix Inc. · Phase 1, Interventional, and Treatment
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Among 558 studies in Asthma with a site in United Kingdom — 52 open to participants now, 71 under way, 11 of them phase 3. Asthma · United Kingdom.
Among the 558 studies in Asthma with a site in United Kingdom, this one is the 242nd largest by enrollment of the 427 interventional ones that give a count, is one of 26 that started in 2018, is one of 81 in phase 1, and was the 355th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →52 of the 558 studies in Asthma with a site in United Kingdom are open now. Recruiting first, the newest first:
Richmond Research Institute · Sites in United Kingdom
Ages 18+
Chiesi Farmaceutici S.p.A. · Sites in United Kingdom
Ages 18–65 · Healthy volunteers
Liverpool Heart and Chest Hospital NHS Foundation Trust · Sites in United Kingdom
Ages 18–110
GlaxoSmithKline · Sites in United Kingdom, United States, Argentina and 1 more country
Ages 18+
University of Leeds · Sites in United Kingdom
Ages 18–70
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
558 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 87 · Phase 2 132 · Phase 3 83 · Phase 4 50
First in 1991; this study’s year is marked. 26 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 58 is below the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 69 across the 427 interventional studies, 149 across the 131 observational. Of the 445 that completed or were terminated, 155 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
320 of 558 have an industry lead sponsor. The 10 most frequent:
Pulmatrix Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Pulmatrix Inc. has 3 studies filed under Asthma — fewer than ten, so there is no comparison to draw.
23 of the studies in Asthma with a site in United Kingdom that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT07833826University of NottinghamN-WATCH: Nottingham Wheeze Assessment in Tidal Children | 2026-12-31 |
| NCT07488897RIGImmune Inc.RIG 101 Trial in Healthy Adults and Adults With Asthma | 2027-02 |
Add all 23 to your calendar (.ics) → With an account.
Among the 558 studies in Asthma with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Phase 1, 3-part study to assess safety, tolerability and PK of single and multiple doses of itraconazole administered as a dry powder for inhalation (PUR1900) in healthy subjects (parts 1 and 2) and a 2-period crossover study of single doses of itraconazole administered as a dry powder for inhalation (PUR1900) and an oral solution (Sporanox) in adults with mild to moderate, stable asthma (part 3)
Phase 1, multi-center, 3-part, open-label study in healthy adults (Parts 1 and 2) and adults with mild to moderate, stable asthma (Part 3).
Safety, tolerability and PK will be assessed following either single ascending (SAD) or multiple ascending (MAD) dosing of itraconazole administered as a dry powder for inhalation (PUR1900; Part 1 and Part 2, respectively). Part 1 will comprise 3 separate cohorts planned to receive single doses of 5, 10 and 25 mg itraconzaole, respectively. The study will have an interleaved design; Part 2 will comprise 2 separate cohorts planned to receive daily doses of itraconazole 10 and 20 mg per day for 14 days, respectively. Part 2, Cohort 1 will commence after a review of safety data from Part 1 Cohort 2 suggests it is safe to do so.
Part 3 is a 2-period, randomised, crossover study in adult subjects with mild to moderate stable asthma to assess the safety, tolerability and PK of single doses of itraconazole administered as a dry powder for inhalation (PUR1900) and administered as an oral solution (Sporanox® Oral Solution).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part 1 (SAD) and Part 2 (MAD):
Part 3 (Asthmatic Subjects):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: drug Itraconzaole powder: single dose of 5mg, 10mg or 25 mg Other name: PUR1900
Drug: Itraconazole Powder
Intervention: drug Itraconzaole powder: 10 mg or 20 mg daily for 14 days Other name: PUR1900
Drug: Itraconazole Powder
Intervention: drug Itraconzaole powder: 20 mg single dose and Itraconzaole oral solution 200 mg single dose Other names: PUR1900, Sporanox
Drug: Itraconazole Powder · Drug: Itraconazole 200 mg
Itraconazole administered as a dry powder for inhalation (PUR1900)
Also known as: PUR1900
Sporanox® Oral Solution
Also known as: Sporanox®
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0
Safety and tolerability will be assessed by evaluating the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
Area under the serum concentration vs time curve from time 0 to infinity (AUC0-inf) of single dose of itraconazole
The area under the serum concentration vs time curve from time 0 to infinity (AUC0-inf)
Time frame: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
Time of the maximum measured serum concentration (Tmax) of single dose of itraconazole
Time of the maximum measured serum concentration (Tmax)
Time frame: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
Area under the serum concentration vs time curve within the dosing interval (AUCtau) of single dose of itraconazole
The area under the serum concentration vs time curve within the dosing interval (AUCtau)
Time frame: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
Apparent first-order terminal elimination half-life (t1/2 ) of single dose of itraconazole
Apparent first-order terminal elimination half-life (t1/2 )
Time frame: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration vs time curve (Kel) of single dose of itraconazole
Apparent first-order terminal elimination rate constant calculated from a semi-log plot of
Time frame: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
Apparent clearance (CL/F) of single dose of itraconazole
Apparent clearance (CL/F)
Time frame: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
Apparent volume of distribution (Vz/F) of single dose of itraconazole
Apparent volume of distribution (Vz/F)
Time frame: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
Maximum Concentration [Cmax] of itraconazole and hydroxyitraconazole in sputum
Exploratory objective: To characterize the concentrations of itraconazole in induced sputum after single doses of inhaled PUR1900 and oral Sporanox® solution in subjects with mild to moderate stable asthma
Time frame: Part 3: baseline through 28 days
Area under the Curve [AUC] of itraconazole and hydroxyitraconazole in sputum
Exploratory objective: To characterize the concentrations of itraconazole in induced sputum after single doses of inhaled PUR1900 and oral Sporanox® solution in subjects with mild to moderate stable asthma
Time frame: Part 3: baseline through 28 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jun 2018, 4 months.
Of 173 industry-sponsored phase 1 interventional studies under Asthma, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 4 months is below that.
Counting every sponsor, half of 200 studies reached it within 6 months; a quarter within 3 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Itraconazole
Pulmatrix Inc.