30 completed, 3 withdrawn, 1 active not recruiting, 1 terminated. 18 Phase 2, 9 Phase 1, 6 Phase 3, 2 Early Phase 1, 2 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 18 | Completed 14, Withdrawn 2, Active not recruiting 1, Terminated 1 |
| Phase 1 | 9 | Completed 7, Withdrawn 2 |
| Phase 3 | 6 | Completed 6 |
| Early Phase 1 | 2 | Completed 2 |
| Not applicable | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder PXS-4728 (A), Matching Placebo (B) - REM Sleep Behavior Disorder | Phase 2 | Active not recruiting | Syntara | 40 | 2023-11-08 | 2026-06-02 |
| Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis PXS-5505 - Myelofibrosis, Primary Myelofibrosis (PMF) | Phase 1 / Phase 2 | Completed | Syntara | 43 | 2021-02-18 | 2026-08-04 |
| A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males PXS-5382A - Pharmacokinetics | Phase 1 | Completed | Syntara | 18 | 2019-12-20 | 2020-06-25 |
| Mannitol-Induced Cough Challenge in Healthy Controls and Subjects With Mild Allergic Asthma Mannitol, Salbutamol 5mg/mL, Sodium Chloride 0.9% Inhl 3Ml - Asthma, Cough | Not applicable | Completed | McMaster University | 40 | 2019-01-11 | 2020-02-17 |
| The Leaky Lung Test Mannitol - Asthma, Allergy | Early Phase 1 | Completed | University of Rochester | 100 | 2015-10-01 | 2018-01-04 |
| A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects Inhaled mannitol, Placebo Comparator: Arm B - Control - Cystic Fibrosis | Phase 3 | Completed | Syntara | 423 | 2014-09-01 | 2020-10-28 |
| Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 Years Inhaled Mannitol, Inhaled Placebo - Cystic Fibrosis | Phase 2 | Completed | Syntara | 95 | 2013-06-01 | 2015-10-14 |
| A Single Blind Study to Evaluate the Safety, Tolerability and Explore the Efficacy of 8.0 mg ASM8 Inhaled Daily for 14 Days in Severe Asthma ASM8 - Asthma | Phase 2 | Withdrawn | Syntara | 2011-11-01 | 2012-12-03 | |
| Efficacy of TPI ASM8 During a 14-Day Allergen Challenge TPI ASM8 - Asthma | Phase 2 | Completed | Syntara | 16 | 2010-11-01 | 2013-11-15 |
| Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis Inhaled mannitol, Matched control - Bronchiectasis | Phase 3 | Completed | Syntara | 485 | 2009-11-01 | 2016-04-29 |
| Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers TPI 1100 - Chronic Obstructive Pulmonary Disease | Phase 1 | Withdrawn | Syntara | 2009-04-01 | 2012-12-03 | |
| Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma TPI ASM8 - Asthma | Phase 2 | Completed | Syntara | 14 | 2009-04-01 | 2013-11-15 |
| Cystic Fibrosis (CF) Flow Rates Study Cystic Fibrosis | Completed | Syntara | 25 | 2009-01-01 | 2009-04-24 | |
| High Dose Inhaled Mannitol Study mannitol - Bronchiectasis | Phase 1 / Phase 2 | Completed | Syntara | 10 | 2009-01-01 | 2010-02-26 |
| Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients Mannitol - Cystic Fibrosis | Phase 1 | Completed | Syntara | 18 | 2008-12-01 | 2010-02-02 |
| Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough bronchial provocation test with mannitol - Cough, Bronchial Hyperreactivity | Not applicable | Completed | Centre Hospitalier Universitaire de Saint Etienne | 30 | 2008-11-01 | 2010-11-24 |
| Long Term Administration of Inhaled Mannitol in Cystic Fibrosis inhaled mannitol, Placebo comparator - Cystic Fibrosis | Phase 3 | Completed | Syntara | 318 | 2008-09-01 | 2020-10-09 |
| A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device dry powder inhaled mannitol - Healthy, Bronchiectasis | Phase 1 / Phase 2 | Completed | Syntara | 15 | 2008-08-01 | 2009-09-18 |
| Inspiratory Flow and Volumes in Bronchiectatics Bronchiectasis | Completed | Syntara | 15 | 2008-06-01 | 2008-08-06 | |
| Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma TPI ASM8, placebo - Allergic Asthma | Phase 2 | Completed | Syntara | 18 | 2008-01-01 | 2013-11-20 |
Showing 20 of 35. Sign in to see all of them.
Asthma (11) · Cystic Fibrosis (9) · Bronchiectasis (5) · Pulmonary Disease, Chronic Obstructive (3) · Cough (2) · Lung Diseases, Obstructive (2) · Bronchial Hyperreactivity (1) · Chronic Cough (1) · Hypersensitivity (1) · Primary Myelofibrosis (1) · REM Sleep Behavior Disorder (1)
Mannitol (14) · TPI ASM8 (4) · Budesonide (3) · Albuterol (2) · NCX 1020 (2) · Case-Control Studies (1) · Inhalation (1) · Ipratropium (1) · Methacholine Chloride (1) · Sodium Chloride (1) · dornase alfa (1)
Australia (14) · Canada (10) · United Kingdom (8) · United States (7) · Argentina (4) · New Zealand (4) · Belgium (3) · France (2) · Germany (2) · Netherlands (2) · Chile (1) · Czechia (1) · Hungary (1) · Ireland (1) · Israel (1)
Brett Charlton (2) · Paul O'Byrne, MD (2) · Rene Pageau, M.Sc Pharm (2) · Alan Barker, MD (1) · Alan James, MBBS (1) · Alvin Ing, MBBS (1) · Andrew Bush, FRCPCH (1) · Andrew Humberstone (1) · Angela Molga, MBBS (1) · Anne Munck, Dr (1) · Brett Charlton, MBBS (1) · Brett Charlton, MBBS PhD (1) · Brett Charlton, MD (1) · Brian O'Connor, MD (1)
PMID 32358807, PMID 33735508, PMID 17337677, PMID 18244953, PMID 18339790, PMID 18972410, PMID 19880909, PMID 19996349, PMID 21478216, PMID 22198974, PMID 23429964, PMID 25246664, PMID 33715994, PMID 40241543
R01HL122424 (1)