You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR CICLESONIDE


✉ Email this page to a colleague

« Back to Dashboard


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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Ciclesonide
Intervention Trials
Asthma 36
Rhinitis, Allergic 31
Rhinitis 31
Rhinitis, Allergic, Seasonal 16
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Ciclesonide

Trials by Country

Trials by Country for Ciclesonide
Location Trials
United States 271
Canada 13
Germany 9
Hungary 8
South Africa 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Ciclesonide
Location Trials
Texas 21
California 18
New Jersey 17
Massachusetts 13
Georgia 13
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Ciclesonide

Clinical Trial Phase

Clinical Trial Phase for Ciclesonide
Clinical Trial Phase Trials
Phase 4 11
Phase 3 51
Phase 2/Phase 3 3
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Ciclesonide
Clinical Trial Phase Trials
Completed 69
Recruiting 3
Unknown status 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Ciclesonide

Sponsor Name

Sponsor Name for Ciclesonide
Sponsor Trials
AstraZeneca 40
Sunovion 13
Takeda 10
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Ciclesonide
Sponsor Trials
Industry 77
Other 27
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Ciclesonide: Clinical Trials, Market Analysis, and Projections

Introduction

Ciclesonide is a third-generation inhaled corticosteroid widely used for the treatment of asthma and allergic rhinitis. This article delves into the recent clinical trials, market analysis, and future projections for ciclesonide, providing a comprehensive overview of its current and potential impact.

Clinical Trials Update

COVID-19 Treatment

Several clinical trials have investigated the efficacy of ciclesonide in treating COVID-19.

  • A multicenter observational study in Japan found that inhaled ciclesonide did not decrease 28-day or in-hospital mortality rates in non-critically ill hospitalized patients with COVID-19. The study involved 3638 patients, with 290 receiving ciclesonide and 3393 in the control group, showing no significant differences in mortality rates between the two groups[1].
  • A randomized clinical trial conducted in the U.S. involving 400 patients with symptomatic COVID-19 found that ciclesonide did not reduce the time to alleviation of all COVID-19-related symptoms. However, patients treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions related to COVID-19[4].

Asthma and Allergic Rhinitis

Ciclesonide has been extensively studied for its efficacy in treating asthma and allergic rhinitis.

  • Studies have shown that ciclesonide is effective in reducing symptoms of asthma and allergic rhinitis due to its unique mechanism of action. It remains in an inactive form until it reaches the lungs, where it is metabolized to its active form, des-ciclesonide, which has high glucocorticoid receptor binding affinity[2][5].

Market Analysis

Market Size and Growth

The global ciclesonide market is projected to grow steadily over the next few years.

  • The market size is estimated to reach $671.7 million by 2027, growing at a CAGR of 2.1% during the forecast period 2022-2027[2].
  • In 2018, the global ciclesonide market was valued at $565.4 million and was expected to witness a CAGR of 1.9% over the forecast period 2018-2026[5].

Geographical Distribution

The market is geographically segmented, with different regions showing varying levels of growth.

  • North America held the largest market share in 2021, driven by the high prevalence of asthma and allergic rhinitis in the U.S. This region is expected to continue dominating the market over the forecast period[2][5].
  • The Asia-Pacific region is projected to have the fastest CAGR during the forecast period due to the extensive application of ciclesonide for treating long-term allergies and asthma in this region[2].

End-User Segmentation

The market is segmented based on end-users, with adults and children being the primary segments.

  • The adults segment held the largest market share in 2021, driven by the increasing use of ciclesonide to prevent asthma attacks in adults. The children segment is expected to grow with a CAGR of 3.1% during the forecast period, driven by the safe and effective use of ciclesonide nasal spray for children with perennial allergic rhinitis[2].

Market Drivers

Increasing Prevalence of Asthma and Allergic Rhinitis

The high prevalence of asthma and allergic rhinitis is a significant driver of the ciclesonide market.

  • According to the Global Asthma Report, asthma affects approximately 339 million people worldwide, and its prevalence is rising, especially in low- and middle-income countries[5].
  • Allergic rhinitis prevalence ranges from 15% to 25% among children, adolescents, and young adults in various regions, contributing to the demand for ciclesonide[5].

Surging Investigations and New Product Launches

Ongoing investigations and new product launches are also driving the market.

  • Ciclesonide is undergoing phase III investigations in the U.S., highlighting its potential as a third-generation inhaled glucocorticoid. The unique features of ciclesonide, such as its activation in the lungs, are fueling its growth[2].
  • Recent approvals, such as the FDA approval for Zetonna (ciclesonide) nasal aerosol in 2012, have expanded the market reach of ciclesonide products[5].

Market Challenges

Limitations and Side Effects

Despite its benefits, ciclesonide faces several challenges.

  • Ciclesonide does not act quickly enough to treat an asthma attack, requiring the use of fast-acting inhalation medications. Side effects such as hives, difficulty breathing, and swelling of the face, lips, tongue, or throat can also hamper its adoption[2].
  • The availability of alternative medications that provide superior treatment for asthma and allergic rhinitis can also impede the growth of the ciclesonide market[2].

Future Projections

Market Growth Potential

The ciclesonide market is expected to continue growing, driven by several factors.

  • The increasing prevalence of asthma and allergic rhinitis, particularly in regions with high pollution levels, will drive the demand for ciclesonide. For instance, high pollution levels increase the likelihood of acute asthma episodes, making ciclesonide a crucial treatment option[5].
  • The Asia-Pacific region, with its large patient pool and growing healthcare infrastructure, is expected to be a key growth area for the ciclesonide market[2].

Opportunities for Market Penetration

There are significant opportunities for market penetration, especially in untapped regions.

  • Key players can focus on markets where the prevalence of allergy rhinitis and asthma is high but the accessibility of ciclesonide is low. Countries in the Asia-Pacific region, such as China, India, and Indonesia, present substantial opportunities due to the underdiagnosis and undertreatment of asthma in these areas[5].

Key Takeaways

  • Ciclesonide has shown mixed results in clinical trials for COVID-19 treatment but remains effective for asthma and allergic rhinitis.
  • The global ciclesonide market is projected to grow, driven by the increasing prevalence of asthma and allergic rhinitis.
  • North America and the Asia-Pacific region are key markets, with the latter expected to show the fastest growth.
  • Despite challenges such as side effects and the availability of alternative treatments, ciclesonide has significant market growth potential.

FAQs

What is the current market size of the ciclesonide market?

The global ciclesonide market is estimated to reach $671.7 million by 2027[2].

What are the primary drivers of the ciclesonide market?

The primary drivers include the increasing prevalence of asthma and allergic rhinitis, surging investigations, and new product launches[2][5].

Which region holds the largest market share for ciclesonide?

North America holds the largest market share, driven by the high prevalence of asthma and allergic rhinitis in the U.S.[2][5].

What are the side effects of ciclesonide?

Side effects include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. Additionally, ciclesonide does not act quickly enough to treat an asthma attack[2].

What are the future growth prospects for the ciclesonide market?

The market is expected to grow, particularly in the Asia-Pacific region, driven by the increasing prevalence of asthma and allergic rhinitis and the penetration into untapped markets[2][5].

Sources

  1. Effect of Inhaled Ciclesonide in Non–Critically Ill Hospitalized Patients with COVID-19. Open Forum Infectious Diseases, 2023.
  2. Ciclesonide Market Size Report, 2022-2027. IndustryARC.
  3. CLINICAL PHARMACOLOGY REVIEW NDA: Proprietary Drug Name. FDA, 2007.
  4. Efficacy of Inhaled Ciclesonide for Outpatient Treatment of COVID-19. JAMA Internal Medicine, 2021.
  5. Ciclesonide Market Size, Trends And Forecast To 2026. Coherent Market Insights.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.