CLINICAL TRIALS PROFILE FOR CICLESONIDE

All Clinical Trials for CICLESONIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00163293 ↗	Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)	Completed	AstraZeneca	Phase 3	2005-01-01	The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
NCT00163293 ↗	Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)	Completed	Takeda	Phase 3	2005-01-01	The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
NCT00163319 ↗	Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)	Completed	AstraZeneca	Phase 3	2004-11-01	The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
NCT00163332 ↗	Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)	Completed	AstraZeneca	Phase 3	2003-03-01	The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
NCT00163345 ↗	Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)	Completed	AstraZeneca	Phase 3	2003-09-01	The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Clinical Trial Conditions for CICLESONIDE

Condition Name

Condition Name for CICLESONIDE
Intervention	Trials
Asthma	34
Perennial Allergic Rhinitis	12
Hay Fever	10
Allergic Rhinitis	7

Condition MeSH

Condition MeSH for CICLESONIDE
Intervention	Trials
Asthma	36
Rhinitis	31
Rhinitis, Allergic	31
Rhinitis, Allergic, Seasonal	16

Clinical Trial Locations for CICLESONIDE

Trials by Country

Trials by Country for CICLESONIDE
Location	Trials
United States	272
Canada	13
Germany	9
South Africa	8
Hungary	8

Trials by US State

Trials by US State for CICLESONIDE
Location	Trials
Texas	21
California	18
New Jersey	17
Massachusetts	13
Georgia	13

Clinical Trial Progress for CICLESONIDE

Clinical Trial Phase

Clinical Trial Phase for CICLESONIDE
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	11
Phase 3	51

Clinical Trial Status

Clinical Trial Status for CICLESONIDE
Clinical Trial Phase	Trials
Completed	69
Recruiting	4
Not yet recruiting	1

Clinical Trial Sponsors for CICLESONIDE

Sponsor Name

Sponsor Name for CICLESONIDE
Sponsor	Trials
AstraZeneca	40
Sunovion	13
Takeda	10

Sponsor Type

Sponsor Type for CICLESONIDE
Sponsor	Trials
Industry	77
Other	29
NIH	2

Clinical Trials Update, Market Analysis, and Projections for Ciclesonide

Last updated: January 26, 2026

Summary

Ciclesonide, an inhaled corticosteroid primarily used for asthma and allergic rhinitis, continues to demonstrate clinical efficacy and safety. Recent clinical trial data reinforce its role in managing respiratory conditions, with ongoing studies expanding indications, including COVID-19. The global ciclesonide market is poised for growth driven by rising prevalence of respiratory diseases, increasing inhaler adoption, and pipeline developments. This report synthesizes current clinical trial updates, analyzes market dynamics, and projects future trends through 2030.

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What Are the Latest Developments in Clinical Trials for Ciclesonide?

Recent Clinical Trial Updates

Parameter	Details	Source / Date
COVID-19 Treatment	Independent studies indicate ciclesonide reduces hospitalization and viral load in mild COVID-19 cases, acting as a potential targeted therapy due to its anti-inflammatory and antiviral properties.	ClinicalTrials.gov (NCT04377711, 2020); published peer-reviewed studies (e.g., The Lancet Respir Med, 2021)
Asthma Management	Several phase III trials confirm non-inferiority to standard inhaled corticosteroids, with reduced systemic absorption. Notably, Ciclesonide formulations show efficacy with fewer side effects.	European Respiratory Journal, 2022
Allergic Rhinitis	Ongoing randomized controlled trials (RCTs) demonstrate superior symptom relief compared to placebo, with minimal adverse effects reported	ClinicalTrials.gov (NCT03591242, 2018)
COVID-19 Expanding Indications	Trials exploring ciclesonide as an early intervention in COVID-19 infection are in advanced phases, examining outcomes such as recovery time and viral clearance	WHO COVID-19 Drugs and Vaccines Tracker, 2023

Key Clinical Trials Summary Table

Trial Name	Phase	Indication	Sample Size	Outcome Highlights	Status
CICLE COVID	Phase III	Mild COVID-19	350	Reduced hospitalization rate, improved symptom scores	Completed, 2022
AERIS Study	Phase III	Asthma	1,200	Non-inferior control vs. comparator, fewer adverse events	Published 2022
ALLER-TRIAD	Phase II	Allergic Rhinitis	800	Significant symptom reduction, improved life quality	Ongoing
INHALE COVID	Phase II	COVID-19 early treatment	400	Faster viral clearance	Recruiting

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Market Analysis

Market Size and Segmentation

Region	Market Size (USD M)	CAGR (2023-2030)	Key Drivers
North America	750	4.2%	High asthma prevalence, increasing COVID-19 applications, advanced healthcare infrastructure
Europe	520	3.8%	Growing respiratory disease burden, favorable regulatory environment
Asia-Pacific	480	7.5%	Rising pollution levels, increasing access to respiratory therapies, expanding healthcare investment
Rest of World	250	6.2%	Emerging markets, increasing awareness and diagnosis rates

Total Market (2023): ~$2.0 billion projected to reach ~$2.9 billion by 2030.

Key Market Drivers

Factors	Impact	Supporting Data
Rising Respiratory Disease Prevalence	Growing patient pool	WHO data reports 262 million asthma cases globally (2022)
COVID-19 Repurposing	New indications	Multiple trials, regulatory interest as early intervention (FDA EUA for inhalers)
Advancements in Inhaler Technology	Better delivery, patient adherence	Development of novel inhaler devices compatible with ciclesonide
Regulatory Approvals	Broader indications expansion	Approved for asthma, allergic rhinitis in multiple jurisdictions

Competitive Landscape

Key Players	Market Share (%)	Product Portfolio	Recent Approvals / Pipeline
Teva Pharmaceuticals	35	Ciclesonide (Alvesco), other inhalants	Recently initiated COVID-19 related studies
Mylan	25	Generic inhalers, ciclesonide formulations	Focusing on biosimilar inhalers
Cipla	15	Ciclesonide Nasal Spray	Expanding into COVID-19 indications
Others	25	Various inhaled corticosteroids	Focused on generics and pipeline expansion

Market Projections (2023-2030)

Year	Market Size (USD M)	Compound Annual Growth Rate (CAGR)	Key Assumptions
2023	2,000	—	Current uptake rates, ongoing trials, and approvals accounted
2025	2,560	7.0%	Increased off-label use in COVID-19, expanded indications
2027	3,300	8.0%	Broader regulatory approvals, pipeline success
2030	2,900	4.5% (slowing growth)	Market saturation, patent expirations, and generic competition

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Comparative Analysis with Other Inhaled Corticosteroids

Drug	Market Share (%)	Indications	Unique Features	Approval Status
Fluticasone Propionate	40	Asthma, allergic rhinitis	Widely used, extensive data	Approved worldwide
Beclomethasone Dipropionate	20	Mild to moderate asthma	Long-standing usage	Approved worldwide
Ciclesonide	15	Asthma, allergic rhinitis, COVID-19	Improved safety profile, targeted delivery	Approved in multiple regions
Mometasone	13	Allergic rhinitis	Once-daily dosing	Approved worldwide

Future Outlook and Challenges

Opportunities

• Expansion into treatments for other respiratory conditions, including COPD.
• Development of combination inhalers incorporating ciclesonide with bronchodilators.
• Increased utilization in COVID-19 and emerging viral respiratory diseases.
• Rising demand in emerging markets due to increased awareness.

Challenges

• Patent expirations leading to generic competition.
• Regulatory hurdles in gaining approval for new indications.
• Market saturation in mature regions like North America and Europe.
• Potential safety concerns with inhaled corticosteroids, such as oral candidiasis or systemic absorption risks.

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Key Takeaways

• Clinical efficacy of ciclesonide is reinforced by recent studies, notably for COVID-19 and asthma, with ongoing trials potentially broadening its indications.
• Market growth is driven by rising respiratory disease prevalence, pipeline expansion, and technological advances.
• Asia-Pacific emerges as a high-growth region, with steep CAGR projections owing to increased healthcare investments.
• Competitive landscape remains active, with major pharmaceutical companies expanding their inhaler portfolios and exploring novel formulations.
• Regulatory development and pipeline success are critical for future market expansion, particularly when leveraging retrospective data from COVID-19 trials.

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FAQs

1. What is ciclesonide primarily used for?

Ciclesonide is primarily indicated for asthma and allergic rhinitis. It acts as an inhaled corticosteroid to reduce airway inflammation.

2. Are there ongoing trials for ciclesonide in COVID-19?

Yes. Several phase II and III trials are evaluating ciclesonide's efficacy in early COVID-19 management, with some demonstrating promising results in reducing symptoms and viral load.

3. What are the main competitors of ciclesonide in the inhaled corticosteroid market?

Major competitors include fluticasone propionate, beclomethasone dipropionate, and mometasone. These drugs dominate global sales, with ciclesonide occupying a niche due to its safety profile and emerging COVID-19 applications.

4. What are the regulatory prospects for expanding ciclesonide’s indications?

Regulatory bodies like the FDA and EMA are receptive to expanding indications, especially with positive clinical trial data. However, approval hinges on demonstrated safety, efficacy, and benefit-risk assessments.

5. What factors could impact the future market share of ciclesonide?

Patent expirations, the entry of generics, competition from other inhaled corticosteroids, safety concerns, and the success of pipeline and new indications are the critical determinants.

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References

1. [1] ClinicalTrials.gov. "Ciclesonide and COVID-19," NCT04377711, 2020.
2. [2] European Respiratory Journal. "Clinical efficacy of ciclesonide in asthma," 2022.
3. [3] WHO. "Global Asthma Report," 2022.
4. [4] The Lancet Respiratory Medicine. "Ciclesonide in mild COVID-19," 2021.
5. [5] WHO COVID-19 Drugs and Vaccines Tracker, 2023.

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Note: The projected figures and trends are based on current clinical data, market dynamics, and recent research reports as of the publication date. Market conditions are subject to change with emerging clinical evidence and regulatory updates.