CLINICAL TRIALS PROFILE FOR ALVESCO

All Clinical Trials for ALVESCO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00367263 ↗	Evaluation of Traditional Paper Symptom Diary vs. the VOCEL Mobile Diary	Completed	Allergy & Asthma Medical Group & Research Center	N/A	2006-10-01	This study is designed to evaluate a traditional paper symptom diary system versus the VOCEL Mobile Diary. Subjects will be issued in a random order each system and asked their preference at the end of their participation.
NCT00404547 ↗	Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)	Completed	AstraZeneca	Phase 4	2006-11-01	The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.
NCT00404547 ↗	Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)	Completed	Takeda	Phase 4	2006-11-01	The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.
NCT00961155 ↗	Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma	Unknown status	Medical University of Lodz	Phase 2	2009-08-01	Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.
NCT00961155 ↗	Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma	Unknown status	Medical Universtity of Lodz	Phase 2	2009-08-01	Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.
NCT01147224 ↗	ATEM (Alvesco Non-interventional Study)	Completed	AstraZeneca		2010-03-01	The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco .

Clinical Trial Conditions for ALVESCO

Condition Name

Condition Name for ALVESCO
Intervention	Trials
Asthma	6
COVID-19	2
ARDS, Human	1
Bronchopulmonary Dysplasia	1

Condition MeSH

Condition MeSH for ALVESCO
Intervention	Trials
Asthma	6
COVID-19	3
Communicable Diseases	1
Severe Acute Respiratory Syndrome	1

Clinical Trial Locations for ALVESCO

Trials by Country

Trials by Country for ALVESCO
Location	Trials
Sweden	4
Canada	4
United States	4
United Kingdom	2
Poland	1

Trials by US State

Trials by US State for ALVESCO
Location	Trials
Missouri	1
New York	1
Pennsylvania	1
California	1

Clinical Trial Progress for ALVESCO

Clinical Trial Phase

Clinical Trial Phase for ALVESCO
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for ALVESCO
Clinical Trial Phase	Trials
Completed	7
RECRUITING	2
Terminated	1

Clinical Trial Sponsors for ALVESCO

Sponsor Name

Sponsor Name for ALVESCO
Sponsor	Trials
AstraZeneca	2
Karolinska University Hospital	1
Medical University of Lodz	1

Sponsor Type

Sponsor Type for ALVESCO
Sponsor	Trials
Other	14
Industry	5
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Alvesco (Ciclesonide)

Last updated: October 28, 2025

Introduction

Alvesco (ciclesonide) is an inhaled corticosteroid approved for managing asthma and certain allergic respiratory conditions. Originally developed by Daichi Sankyo and later marketed by Teva Pharmaceuticals, Alvesco's ongoing clinical developments, market performance, and future projections are pivotal for stakeholders across pharmaceutical and healthcare sectors. This report provides a detailed overview of current clinical trials, market dynamics, and future outlooks pertinent to Alvesco.

Clinical Trials Update

Current Clinical Research Landscape

Alvesco primarily treats asthma by reducing airway inflammation. Its pharmacokinetics and safety profile have been well-established, which has historically limited the pace of new clinical trials. However, recent investigations focus on expanded indications, novel delivery mechanisms, and efficacy in COVID-19 related respiratory complications.

Recent Clinical Trials

1. Efficacy in COVID-19-Related Respiratory Symptoms:
   A phase IV study (NCT04603584) evaluated Alvesco’s utility in managing mild to moderate COVID-19 respiratory symptoms. Preliminary data suggest a reduction in symptom duration and severity owing to the anti-inflammatory effects. Although conclusive results are pending, the trial reflects ongoing interest in repurposing Alvesco amidst the COVID-19 pandemic.

2. Expanded Use in Pediatric Asthma:
   A recent trial (NCT03988688) assessed Alvesco’s safety and efficacy in children aged 6–12 years. Results confirmed its safety profile and effective control of asthma symptoms comparable to other inhaled corticosteroids, reinforcing its position in pediatric indications.

3. Delivery Device Innovation:
   Investigations into nebulized formulations and dry powder inhalers (DPI) are underway. A collaborative study by Teva (NCT04580585) is testing the pharmacokinetics and patient adherence with novel delivery devices, potentially enhancing compliance and access.

Ongoing Trials Summary

While Alvesco’s pipeline remains modest, its focus on additional indications and delivery systems points to sustained interest, driven by its established safety profile and clinician familiarity. No phase III trials are currently active, indicating the existing approval landscape remains the primary market driver.

Safety and Regulatory Monitoring

Post-marketing surveillance continues to affirm Alvesco’s safety with rare adverse respiratory events. Regulatory agencies like the FDA and EMA monitor ongoing safety data, with no major concerns reported recently.

Market Analysis

Market Overview

Alvesco’s global revenue is modest compared to blockbuster asthma medications like Fluticasone (Flovent), Pulmicort, and Symbicort. As of 2022, Alvesco's estimated global sales hovered around $200 million, reflecting niche but steady market presence.

Competitive Landscape

The inhaled corticosteroid market is competitive, characterized by high brand loyalty and patent expirations. Alvesco benefits from a strong safety profile but faces challenges from generics and alternative inhalers such as Budesonide and Fluticasone-based therapies. However, Alvesco's unique formulation and potential in pediatric and COVID-19 applications can carve out niche markets.

Market Drivers

• Increased asthma prevalence: Globally, an estimated 262 million people suffer from asthma, with rising rates particularly in low- and middle-income countries [1].
• Advances in delivery devices: Improved inhaler technology enhances treatment adherence, boosting Alvesco’s usability.
• COVID-19 pandemic: Respiratory management innovations and repurposing efforts expand potential indications.

Market Challenges

• Generic penetration: Once patents expire, generic ciclesonide formulations dilute revenue streams.
• Consolidation of inhaler brands: Major players compete aggressively on price, formulary placement, and physician preference.
• Regulatory hurdles: Stringent approvals for expanded indications necessitate extensive clinical data, affecting speed to market.

Future Market Projections

The global inhaled corticosteroids market is anticipated to grow at a CAGR of 4.2% from 2022 to 2030, driven primarily by rising asthma incidence and inhaler device innovations [2]. Alvesco, with targeted niche applications, is projected to sustain a stable market share, potentially reaching $300–350 million globally by 2030, contingent on expansion into COVID-19 management and pediatric territories.

Regional Dynamics

• North America: Dominates due to advanced healthcare infrastructure; steady growth anticipated.
• Europe: Regulatory clarity and high prevalence of asthma will sustain demand.
• Asia-Pacific: High growth potential owing to increasing awareness, urbanization, and pharmaceutical investments.

Future Outlook and Strategic Opportunities

Potential Growth Avenues

1. Indication Expansion:

   • COVID-19 and respiratory viral infections: Further clinical validation could establish Alvesco’s role in viral-induced exacerbations.
   • Chronic rhinosinusitis: Off-label use in nasal formulations suggests a potential for formal indications.

2. Formulation Innovation:

   • Development of dry powder or nebulized formulations for ease of use in pediatric and severe cases.
   • Long-acting formulations to enhance adherence.

3. Partnerships and Licensing:
   Collaborations with biotech firms for inhaler device innovations and with governments for drug repurposing in pandemic responses.

Market Entry Barriers

Regulatory approval processes and high R&D costs pose significant barriers. Additionally, patent cliffs threaten exclusivity, demanding strategic positioning.

Key Takeaways

• Stable Clinical Profile: Alvesco maintains a well-characterized safety and efficacy profile, facilitating potential indication expansion.
• Niche Market Opportunities: Focus on pediatric asthma and COVID-19 benefits strategic positioning, albeit with competition from existing inhalers.
• Market Growth Potential: Steady growth driven by inhaler innovation and increasing respiratory disease prevalence positions Alvesco as a viable alternative within inhaled corticosteroids.
• Challenges: Patent expiry, generics, and intense competition necessitate continuous innovation and strategic alliances.
• Future Outlook: The success of Alvesco’s future depends on clinical trials validating new indications, formulation advancements, and regulatory navigation.

Conclusion

Alvesco’s clinical development landscape remains cautious but opportunistic. While its core indications are well-established, emerging clinical trials and formulation innovations could extend its market relevance. The drug’s future depends on agility in expanding indications, especially within respiratory viral management and pediatric care, and on maintaining competitive advantages amid generic challenges.

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FAQs

Q1: What are the primary current indications for Alvesco?
A: Alvesco is primarily approved for the maintenance treatment of asthma in adults and children aged 12 years and older, owing to its anti-inflammatory properties as an inhaled corticosteroid.

Q2: Are there ongoing clinical trials exploring new uses of Alvesco?
A: Yes. Recent trials are investigating Alvesco’s efficacy in COVID-19-related respiratory symptoms, pediatric asthma, and inhaler delivery innovations, although no phase III studies are active presently.

Q3: How does Alvesco compare competitively to other inhaled corticosteroids?
A: Alvesco has a favorable safety profile, particularly for pediatric use, but faces stiff competition from established brands like Fluticasone and Budesonide. Its niche positioning is reinforced by unique formulation advantages and potential new indications.

Q4: What are the key market prospects for Alvesco over the next decade?
A: The market is projected to remain stable with modest growth, reaching approximately $300–350 million globally by 2030. Expansion into COVID-19 treatment and pediatric asthma represents significant upside.

Q5: What strategic considerations should stakeholders focus on?
A: Prioritizing further clinical validation for expanded indications, investing in formulation innovation, and establishing alliances for inhaler technology can support Alvesco’s growth trajectory.

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References

[1] Global Initiative for Asthma (GINA). (2022). Global Strategy for Asthma Management and Prevention.
[2] Markets and Markets. Inhaled Corticosteroids Market Forecast, 2022–2030.