Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the efficacy and safety of ciclesonide across various conditions, including bronchial asthma, perennial and seasonal allergic rhinitis, and chronic rhinosinusitis with polyps. Led by major pharmaceutical sponsors and academic institutions, these studies encompass completed, recruiting, terminated, and withdrawn protocols. Across pediatric and adult patient cohorts, these investigations assess parameters including airway hyperresponsiveness, systemic exposure, and symptomatic relief.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06589245 | RECRUITING | Bronchopulmonary Dysplasia |
Venkatesh Sampath |
2025-09-16 | PHASE1 |
| NCT04870333 | COMPLETED | Covid19 |
Cambridge University Hospitals NHS Foundation Trust |
2021-02-19 | PHASE2; PHASE3 |
| NCT04356495 | COMPLETED | Corona Virus Infection; Sars-CoV2 |
University Hospital, Bordeaux |
2020-07-29 | PHASE2; PHASE3 |
| NCT04381364 | UNKNOWN | Covid-19; Pneumonia, Viral; Sars-CoV2 |
Ola Blennow, MD, PhD |
2020-05-29 | PHASE2 |
| NCT04435795 | TERMINATED | COVID 19 |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2020-09-15 | PHASE2; PHASE3 |
| NCT04330586 | COMPLETED | COVID-19 |
Korea University Guro Hospital |
2020-04-01 | PHASE2 |
| NCT04377711 | COMPLETED | COVID-19 |
Covis Pharma S.à.r.l. |
2020-06-08 | PHASE3 |
| NCT02665806 | UNKNOWN | Chronic Rhinosinustis With Polyps |
Tehran University of Medical Sciences |
2016-01 | PHASE3 |
| NCT02155881 | COMPLETED | Seasonal Allergic Rhinitis |
AstraZeneca |
2014-08 | PHASE3 |
| NCT01455194 | COMPLETED | Bronchial Asthma |
AstraZeneca |
2011-11 | PHASE3 |
| NCT01248065 | COMPLETED | Asthma |
Milton S. Hershey Medical Center |
2011-04 | PHASE3 |
| NCT01171365 | COMPLETED | Asthma |
University of Nottingham |
2010-01 | PHASE4 |
| NCT01654536 | COMPLETED | Perennial Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2012-09 | PHASE4 |
| NCT01458275 | COMPLETED | Seasonal Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2011-11 | PHASE3 |
| NCT01451541 | COMPLETED | Perennial Allergic Rhinitis; PAR |
Sumitomo Pharma America, Inc. |
2011-10 | PHASE3 |
| NCT01430260 | COMPLETED | Allergic Rhinitis |
Handok Inc. |
2011-01 | PHASE4 |
| NCT01378429 | COMPLETED | Perennial Allergic Rhinitis; PAR |
Sumitomo Pharma America, Inc. |
2011-07 | PHASE3 |
| NCT01401465 | COMPLETED | Perennial Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2011-07 | PHASE3 |
| NCT01371786 | COMPLETED | Allergic Rhinitis (AR) |
Sumitomo Pharma America, Inc. |
2011-06 | PHASE1 |
| NCT02273817 | COMPLETED | Seasonal Allergic Rhinitis |
Apotex Inc. |
2011-03 | PHASE3 |
| NCT01287364 | COMPLETED | Perennial Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2011-02 | PHASE3 |
| NCT01333800 | COMPLETED | Asthma |
Grünenthal Colombiana S.A. |
2010-07 | PHASE4 |
| NCT01067105 | COMPLETED | Perennial Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2010-02 | PHASE3 |
| NCT00826969 | COMPLETED | Asthma |
AstraZeneca |
2008-09 | PHASE4 |
| NCT01033825 | COMPLETED | Perennial Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2010-01 | PHASE3 |
| NCT01147224 | Completed | Asthma|Allergy |
AstraZeneca |
2010-03 | -- |
| NCT01010971 | COMPLETED | Seasonal Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2009-12 | PHASE3 |
| NCT00953147 | COMPLETED | Allergic Rhinitis; Perennial Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2009-08 | PHASE3 |
| NCT00793858 | WITHDRAWN | Allergic Rhinitis |
University of Chicago |
2009-02 | PHASE4 |
| NCT00163293 | COMPLETED | Asthma |
AstraZeneca |
2005-01-01 | PHASE3 |
| NCT00793858 | Withdrawn | Allergic Rhinitis |
University of Chicago|Sumitomo Pharma America Inc. |
2009-02 | Phase 4 |
| NCT00790023 | COMPLETED | Seasonal Allergic Rhinitis |
Sumitomo Pharma America, Inc. |
2008-11 | PHASE3 |
| NCT00826969 | Completed | Asthma |
AstraZeneca |
2008-09 | Phase 4 |
| NCT02221375 | COMPLETED | Healthy |
Boehringer Ingelheim |
2008-06 | PHASE1 |
| NCT00535366 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
Boehringer Ingelheim |
2007-10 | PHASE2 |
| NCT00306163 | COMPLETED | Asthma |
AstraZeneca |
2006-05 | PHASE3 |
| NCT03839433 | COMPLETED | Asthma, Bronchial |
Cantonal Hospital, Baselland |
2007-06 | PHASE4 |
| NCT00404547 | COMPLETED | Asthma |
AstraZeneca |
2006-11 | PHASE4 |
| NCT00458835 | COMPLETED | Allergic Rhinitis |
Covis Pharma S.à.r.l. |
2007-04 | PHASE4 |
| NCT00392288 | COMPLETED | Asthma |
AstraZeneca |
2006-09 | PHASE3 |
| NCT00525772 | COMPLETED | Asthma |
Hamilton Health Sciences Corporation |
2001-11 | PHASE3 |
| NCT00384189 | COMPLETED | Asthma |
AstraZeneca |
2006-09 | PHASE3 |
| NCT00807053 | COMPLETED | Rhinitis, Allergic, Seasonal |
AstraZeneca |
2007-04 | PHASE2 |
| NCT00806754 | COMPLETED | Rhinitis, Allergic, Perennial |
AstraZeneca |
2006-11 | PHASE4 |
| NCT00458835 | Completed | Allergic Rhinitis |
Covis Pharma S.à.r.l. |
2007-04 | Phase 4 |
| NCT00305461 | COMPLETED | Asthma |
AstraZeneca |
2006-02 | PHASE3 |
| NCT00174720 | COMPLETED | Asthma |
Sanofi |
2005-09 | PHASE3 |
| NCT00384475 | COMPLETED | Rhinitis, Allergic, Seasonal; Hay Fever |
AstraZeneca |
2006-10 | PHASE3 |
| NCT00163449 | COMPLETED | Asthma |
AstraZeneca |
2005-11 | PHASE3 |
| NCT00367263 | Completed | Asthma |
Allergy & Asthma Medical Group & Research Center |
2006-10 | Not Applicable |
| NCT00305487 | COMPLETED | Hay Fever; Seasonal Allergic Rhinitis |
AstraZeneca |
2006-03 | PHASE3 |
| NCT00261287 | COMPLETED | Hay Fever; Perennial Allergic Rhinitis |
AstraZeneca |
2005-11 | PHASE3 |
| NCT00163345 | COMPLETED | Asthma |
AstraZeneca |
2003-09 | PHASE3 |
| NCT00174733 | COMPLETED | Asthma |
Sanofi |
2005-07 | PHASE3 |
| NCT00163436 | COMPLETED | Asthma |
AstraZeneca |
2005-09 | PHASE3 |
| NCT00314509 | COMPLETED | Asthma |
AstraZeneca |
2005-07 | PHASE2 |
| NCT00163423 | COMPLETED | Asthma |
AstraZeneca |
2004-11 | PHASE3 |
| NCT00163371 | COMPLETED | Asthma |
AstraZeneca |
2005-09 | PHASE3 |
| NCT00174746 | COMPLETED | Asthma |
Sanofi |
2005-03 | PHASE2 |
| NCT00163462 | COMPLETED | Asthma |
AstraZeneca |
2004-10 | PHASE3 |
| NCT00163358 | COMPLETED | Asthma |
AstraZeneca |
2003-09 | PHASE3 |
| NCT00163488 | COMPLETED | Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever |
AstraZeneca |
2005-01 | PHASE3 |
| NCT00163514 | COMPLETED | Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever |
AstraZeneca |
2004-05 | PHASE3 |
| NCT00163397 | COMPLETED | Asthma |
AstraZeneca |
2004-01 | PHASE3 |
| NCT00254956 | COMPLETED | Respiratory Tract Diseases; Respiratory Hypersensitivity; Asthma |
Sanofi |
2004-01 | PHASE3 |
| NCT00163384 | COMPLETED | Asthma |
AstraZeneca |
2004-01 | PHASE3 |
| NCT00659048 | COMPLETED | Rhinitis, Allergic, Perennial |
AstraZeneca |
2004-12 | PHASE3 |
| NCT00658918 | COMPLETED | Rhinitis, Allergic, Perennial; Hay Fever |
AstraZeneca |
2004-09 | PHASE3 |
| NCT00659503 | COMPLETED | Rhinitis, Allergic, Seasonal; Hay Fever |
AstraZeneca |
2005-02 | PHASE3 |
| NCT00163501 | COMPLETED | Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever |
AstraZeneca |
2003-12 | PHASE3 |
| NCT00659594 | COMPLETED | Rhinitis, Allergic, Seasonal; Hay Fever |
AstraZeneca |
2004-11 | PHASE3 |
| NCT00659841 | COMPLETED | Rhinitis, Allergic, Seasonal; Hay Fever |
AstraZeneca |
2003-12 | PHASE3 |
| NCT00163410 | COMPLETED | Asthma |
AstraZeneca |
2003-04 | PHASE3 |
| NCT00659750 | COMPLETED | Rhinitis, Allergic, Perennial |
AstraZeneca |
2003-12 | PHASE3 |
| NCT00546520 | COMPLETED | Asthma |
AstraZeneca |
2002-04 | PHASE3 |
| NCT00270348 | COMPLETED | Asthma |
Sanofi |
2000-12 | PHASE3 |
| NCT00163332 | COMPLETED | Asthma |
AstraZeneca |
2003-03 | PHASE3 |
| NCT00163319 | COMPLETED | Asthma |
AstraZeneca |
2004-11 | PHASE3 |
| NCT00367263 | COMPLETED | Asthma |
Allergy & Asthma Medical Group & Research Center |
2006-10 |
(data from https://clinicaltrials.gov, updated on 2026-03-27)
Check the
Ciclesonide
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.