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.
NCT00163358 ↗	Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)	Completed	AstraZeneca	Phase 3	2003-09-01	The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). 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
Georgia	13
Massachusetts	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
Terminated	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

Ciclesonide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Ciclesonide, an inhaled corticosteroid primarily used for asthma and allergic rhinitis, has garnered renewed interest due to its evolving therapeutic profile and potential applicability beyond its traditional indications. This article evaluates the latest clinical trial developments, conducts a comprehensive market analysis, and offers future projections to inform investment, R&D strategies, and competitive positioning within the respiratory therapeutics landscape.

Clinical Trials Update on Ciclesonide

Recent Clinical Trials and Emerging Data

Over the past two years, clinical research has expanded beyond its established use in asthma and allergic rhinitis to explore novel applications, notably in the context of COVID-19 and other inflammatory respiratory conditions.

COVID-19 and Respiratory Inflammation

Ciclesonide’s anti-inflammatory and antiviral properties have prompted multiple studies during the COVID-19 pandemic. Notably, Phase II/III trials evaluated inhaled ciclesonide as an outpatient treatment to reduce viral replication and mitigate disease progression. Preliminary findings suggest a reduction in the incidence of hospitalization and symptom duration when administered early in infection (e.g., the CICLECOVID trial). However, results remain mixed, and larger, more definitive studies are ongoing. Both NCT04377785 and NCT04581388 have made incremental progress in validating ciclesonide’s role in managing COVID-19-related respiratory complications.

Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Clinical trials for asthma continue to confirm ciclesonide’s safety and efficacy. Recent Phase IV studies focus on dosing optimization, long-term safety, and reduced systemic corticosteroid exposure. A notable trial, NCT04422681, investigated its use in pediatric asthma with positive outcomes regarding lung function improvement and reduced exacerbations.

Similarly, investigations in COPD (e.g., NCT04514294) aim to delineate ciclesonide’s anti-inflammatory benefits in a broader spectrum of obstructive airway diseases, with preliminary data indicating favorable safety profiles and symptom control enhancements.

Other Indications

Research has expanded into nasal corticosteroid applications for allergic rhinitis and sinusitis, with ongoing trials assessing efficacy, quality of life improvements, and safety in these indications.

Key Developments and Regulatory Insights

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to review existing data to potentially expand approved indications. Notably, in 2021, the FDA granted Orphan Drug Designation for ciclesonide in managing certain rare inflammatory airway conditions, which might expedite future approval pathways.

Overall, the clinical pipeline suggests steady progress, yet definitive evidence supporting broader indications remains under evaluation.

Market Analysis of Ciclesonide

Market Size and Segments

Current Market Landscape

The global inhaled corticosteroid market was valued at approximately $4.5 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% (source: Grand View Research). Ciclesonide, marketed mainly as Alvesco® (by AstraZeneca), accounts for a significant share within this niche, particularly in the inhaled corticosteroid segment used for asthma.

Key Market Players

• AstraZeneca (Alvesco®): Dominates, leveraging established sales and physician familiarity.
• Teva Pharmaceutical Industries: Offers generic versions, focusing on cost-sensitive markets.
• Other Competitors: Fluticasone, budesonide, and mometasone products dominate inhaled corticosteroid prescriptions, constraining ciclesonide’s market share.

Regional Dynamics

• North America: Largest market owing to high asthma prevalence and advanced healthcare infrastructure.
• Europe: Strong adoption, with increased penetration due to updated clinical guidelines.
• Asia-Pacific: Rapid growth anticipated, driven by rising respiratory disease incidence and expanding healthcare access.

Market Drivers and Challenges

Drivers

• Growing Asthma and COPD Prevalence: Estimated at approximately 262 million asthma sufferers globally.
• Increased Adoption of Inhaled Therapies: Emphasis on inhaled corticosteroids aligns with guidelines promoting their use as first-line therapy.
• Emerging Applications: Trials exploring antiviral and anti-inflammatory roles open new revenue streams.
• Pipeline Expansion Aspirations: R&D investments targeting broader indications.

Challenges

• Competitive Landscape: Established inhaled corticosteroids like fluticasone and budesonide dominate prescribing patterns.
• Patent Expirations and Generics: Potential erosion of margins for branded ciclesonide products.
• Clinical Evidence for New Indications: Validation hurdles limit off-label expansion.

Distribution and Commercial Strategies

Pharmaceutical companies are increasingly focusing on direct-to-consumer marketing, physician education, and partnerships with healthcare providers to maintain market share. Precision medicine approaches and personalized therapy strategies are emerging trends, potentially influencing ciclesonide’s positioning.

Future Projections

Market Growth Outlook (2023–2030)

Based on current trends, the inhaled corticosteroid market is expected to grow at a CAGR of 3.8%–4.5%. Ciclesonide’s niche positioning, coupled with ongoing clinical trials, could position it as a key player in expanded therapeutic areas, especially if emerging evidence confirms efficacy in viral respiratory infections.

Potential Market Penetration

• 2025: Expected to reach $6.1 billion globally.
• 2030: Anticipated to approach $8 billion, contingent upon successful approval for new indications and continued adoption in existing markets.

Impact of COVID-19 and Future Respiratory Pandemics

The increased focus on respiratory antivirals following COVID-19 pandemic lessons could accelerate ciclesonide’s incorporation into treatment protocols if trial results solidify its efficacy. Regulatory agencies might also expedite approval processes for repurposed drugs with promising safety profiles.

Regulatory and Scientific Milestones

• FDA and EMA Expansion: Approvals for indications like viral respiratory infections could substantially boost market size.
• Combination Therapies: Integration with novel agents (e.g., biologics) may open adjunct therapy markets.
• Digital and Personalized Medicine: Smart inhalers and biomarker-driven approaches could improve therapeutic targeting, favoring ciclesonide-based regimens.

Key Takeaways

• Clinical Progress: Ongoing trials in COVID-19, asthma, COPD, and allergic rhinitis remain promising but require further validation for broader approval.
• Market Positioning: Ciclesonide faces stiff competition from established inhaled corticosteroids but benefits from targeted clinical data supporting safety and efficacy.
• Growth Opportunities: Expanding indications, particularly in viral respiratory illnesses and international markets, can elevate market share.
• Strategic Focus: Investment in clinical research, regulatory engagement, and strategic partnerships is essential to capitalize on upcoming opportunities.
• Regulatory Landscape: Accelerated approvals for COVID-related use and orphan indications could significantly impact revenue streams.

FAQs

1. What are the primary therapeutic uses of ciclesonide today?
   Ciclesonide is predominantly prescribed for asthma and allergic rhinitis, leveraging its anti-inflammatory properties delivered via inhalation.

2. Has ciclesonide been approved for COVID-19 treatment?
   While not officially approved solely for COVID-19, clinical trials suggest potential benefits in early outpatient management, prompting off-label use and further investigation.

3. What are the main competitors of ciclesonide in the inhaled corticosteroid market?
   Fluticasone, budesonide, and mometasone dominate the market, with extensive generic options and well-established prescribing habits.

4. What challenges does ciclesonide face in expanding its indications?
   Challenges include proving efficacy through large-scale clinical trials, regulatory hurdles, and competition from existing therapies.

5. What is the outlook for ciclesonide over the next decade?
   A cautiously optimistic outlook exists if ongoing trials confirm broader applications, with potential expansion into antiviral and rare inflammatory indications, driving revenue growth and market penetration.

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Sources

1. Grand View Research. Inhaled Corticosteroids Market Size, Share & Trends Analysis Report. 2022.
2. ClinicalTrials.gov. US National Library of Medicine. Various trial identifiers cited.
3. AstraZeneca. Alvesco Product Information. 2022.
4. World Health Organization. Asthma Fact Sheet. 2021.