CLINICAL TRIALS PROFILE FOR PULMICORT RESPULES

All Clinical Trials for Pulmicort Respules

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00388739 ↗	Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department	Withdrawn	AstraZeneca	N/A	2006-11-01	Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory medication will result in an improvement of ED revisits (and unscheduled return visits). Chronic management intitiation in conjunction with an asthma educational intervention in the pediatric ED with anti-inflammatory medication will also result in improved Quality of Life measure. Specific aims: 1. To demonstrate that the initiation controller medication therapy in conjunction with asthma education will result in: 1. Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period 2. Improved Quality of Life as measured by Bukstein's ITG Quality of Life measure. 2. To describe the relationship of the initiation of controller medication therapy in conjunction with asthma education with well child visits, missed school/daycare days and behavioral capabilities. Objective: To determine the impact of beginning chronic asthma medication regimens after an educational intervention in the ED in pediatric patients 1-18 years of age with mild to moderate persistent asthma. Long-term goal/purpose: To demonstrate the success of a model of care that utilizes the emergency department physician to initiate National Asthma Education and Prevention Program (NAEPP) guided chronic asthma therapy in children 1-18 years of age. This model will attempt to bridge the gap in initiation of chronic asthma therapy currently left by a failure of both emergency department and primary care physicians.
NCT00388739 ↗	Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department	Withdrawn	Baylor College of Medicine	N/A	2006-11-01	Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory medication will result in an improvement of ED revisits (and unscheduled return visits). Chronic management intitiation in conjunction with an asthma educational intervention in the pediatric ED with anti-inflammatory medication will also result in improved Quality of Life measure. Specific aims: 1. To demonstrate that the initiation controller medication therapy in conjunction with asthma education will result in: 1. Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period 2. Improved Quality of Life as measured by Bukstein's ITG Quality of Life measure. 2. To describe the relationship of the initiation of controller medication therapy in conjunction with asthma education with well child visits, missed school/daycare days and behavioral capabilities. Objective: To determine the impact of beginning chronic asthma medication regimens after an educational intervention in the ED in pediatric patients 1-18 years of age with mild to moderate persistent asthma. Long-term goal/purpose: To demonstrate the success of a model of care that utilizes the emergency department physician to initiate National Asthma Education and Prevention Program (NAEPP) guided chronic asthma therapy in children 1-18 years of age. This model will attempt to bridge the gap in initiation of chronic asthma therapy currently left by a failure of both emergency department and primary care physicians.
NCT00584636 ↗	Pulmicort Respules on Relapse Rates After Treatment in the ED	Withdrawn	Phoenix Children's Hospital	Phase 4	2007-10-01	The purpose of this study is to see if the addition of budesonide to oral corticosteroids will result in a decrease in relapse rates compared to oral corticosteroids alone in children who are discharged from the ED after an asthma exacerbation. Secondly, that there will be an improvement in lung function, a decrease in beta-2 agonist use and an improvement in health-related quality of life compared to placebo.
NCT00588406 ↗	Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.	Completed	AstraZeneca	Phase 3	2007-09-01	To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.

Clinical Trial Conditions for Pulmicort Respules

Condition Name

Condition Name for Pulmicort Respules
Intervention	Trials
Asthma	10
Sinusitis	2
COPD	1
Lung Cancer	1

Condition MeSH

Condition MeSH for Pulmicort Respules
Intervention	Trials
Asthma	10
Emergencies	2
Sinusitis	2
Lung Neoplasms	1

Clinical Trial Locations for Pulmicort Respules

Trials by Country

Trials by Country for Pulmicort Respules
Location	Trials
United States	8
Japan	3
Australia	1

Trials by US State

Trials by US State for Pulmicort Respules
Location	Trials
Arizona	2
Texas	2
Oklahoma	1
Connecticut	1
North Carolina	1

Clinical Trial Progress for Pulmicort Respules

Clinical Trial Phase

Clinical Trial Phase for Pulmicort Respules
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Pulmicort Respules
Clinical Trial Phase	Trials
Completed	8
Withdrawn	3
Unknown status	2

Clinical Trial Sponsors for Pulmicort Respules

Sponsor Name

Sponsor Name for Pulmicort Respules
Sponsor	Trials
AstraZeneca	7
Phoenix Children's Hospital	2
Allergan	1

Sponsor Type

Sponsor Type for Pulmicort Respules
Sponsor	Trials
Industry	11
Other	9

Pulmicort Respules: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Pulmicort Respules, a nebulizer formulation of the inhaled corticosteroid Budesonide, remains a cornerstone in pediatric asthma management globally. Its efficacy, safety profile, and ease of administration have sustained its clinical relevance. This report offers a comprehensive update on its ongoing clinical trials, evaluates current market dynamics, and projects future growth opportunities within the respiratory therapeutic landscape.

Clinical Trials Landscape for Pulmicort Respules

Ongoing and Recent Clinical Trials

Though Pulmicort Respules has a well-established profile, recent clinical trials focus on expanding its indications, optimizing dosing protocols, and evaluating long-term safety in diverse populations.

• Asthma Management in Pediatric Populations: Recent Phase IV studies evaluate the safety and efficacy of Pulmicort Respules in children under five, aiming to confirm optimal dosing strategies to minimize side effects while maintaining disease control [1].

• Steroid-Sparing Regimens: Trials are exploring combination therapy with biologics, such as anti-IgE agents, to reduce corticosteroid exposure without compromising efficacy [2].

• Novel Delivery Techniques: Innovations such as improved nebulizer systems are under clinical assessment to enhance pulmonary deposition and reduce treatment burden, notably in low-resource settings [3].

Regulatory Post-Marketing Studies

Regulatory agencies continuously monitor Pulmicort Respules’ post-marketing performance, with ongoing studies assessing rare adverse events in pediatric subgroups, ensuring its benefit-risk balance remains favorable.

Market Dynamics and Competitive Landscape

Market Overview

Pulmicort Respules continues to command significant market share within pediatric asthma therapeutics. Global sales are fueled by increasing asthma prevalence, particularly among children in developing economies, and rising adoption of inhaled corticosteroids as first-line therapy.

• Market Size: The global pediatric asthma medication market was valued at approximately US$6 billion in 2022 and is projected to grow at a CAGR of 5.8% through 2030 [4].

• Geographic Trends: North America dominates the market, attributable to high diagnosis rates and healthcare infrastructure, while Asia-Pacific exhibits fastest growth owing to expanding healthcare access and urbanization.

Key Competitors

While Pulmicort Respules holds a strong position, it faces competition primarily from other corticosteroid inhalation formulations and biologic agents:

• Fluticasone Propionate (e.g., Flovent): A key competitor with similar efficacy but differing in delivery devices.

• Beclomethasone Dipropionate: Available as a nebulized alternative, with varying efficacy profiles.

• Biologics (e.g., Omalizumab): Emerging as advanced options in severe pediatric asthma cases, potentially impacting corticosteroid reliance.

Market Challenges

• Generic Competition: Patent expirations and availability of generics threaten premium pricing and market share.

• Inhalation Device Technology: Advancements in dry powder inhalers (DPIs) and meter-dose inhalers (MDIs) challenge traditional nebulizer-based formulations.

• Regulatory and Reimbursement Dynamics: Price controls and reimbursement restrictions in certain markets may impact sales growth.

Future Market Projections

Growth Drivers

• Expanding Pediatric Asthma Diagnoses: As awareness increases, earlier diagnosis and intervention are likely to boost Pulmicort Respules' usage.

• Innovation in Drug Delivery: Development of user-friendly, portable nebulizers with integrated smart technology may enhance adherence, especially among younger children.

• Emerging Markets: Rapid urbanization in Asia-Pacific and Africa is expected to escalate demand for pediatric nebulized corticosteroids.

Potential Market Barriers

• Shift Toward Biologic Therapies: For severe cases, biologics may supplant corticosteroids, constraining growth in specific subpopulations.

• Cost Considerations: High treatment costs and limited insurance coverage in emerging economies could hinder accessibility.

Projected Market Growth (2023–2030)

Based on current trends, the market for Pulmicort Respules and equivalent nebulized corticosteroid therapies is anticipated to grow at a CAGR of approximately 4.5–6%, reaching an estimated US$8–9 billion by 2030 [5].

Strategic Recommendations

• Innovation Focus: Emphasize the development of advanced nebulizer systems that improve drug deposition and patient compliance.

• Market Penetration: Expand in emerging markets through partnerships with local distributors and tailored educational programs.

• Differentiation: Highlight Pulmicort Respules' proven safety profile and clinical efficacy in pediatric populations to differentiate from newer modalities.

• Regulatory Engagement: Proactively collaborate with regulatory bodies to facilitate approvals for new indications and formulations.

Key Takeaways

• Pulmicort Respules remains a pivotal therapy with ongoing clinical trials focusing on dosing optimization, safety, and novel delivery methods.
• The global market maintains strong growth driven by rising pediatric asthma prevalence, technology improvements, and expanding access in emerging economies.
• Competitive pressures from generic inhaled corticosteroids and biologic agents necessitate continuous innovation and strategic positioning.
• Future growth hinges on technological advancements in drug delivery, market expansion, and adaptation to evolving therapeutic paradigms.
• Stakeholders must monitor regulatory environments and demographic trends to capitalize on emerging opportunities.

FAQs

1. What are the primary clinical benefits of Pulmicort Respules for pediatric asthma?
   Pulmicort Respules deliver effective anti-inflammatory action, reducing airway inflammation, decreasing exacerbations, and improving overall asthma control in children, with a well-established safety profile.

2. Are there any recent developments in Pulmicort Respules' clinical trials?
   Recent studies explore dose optimization in very young children, combination therapies with biologics, and innovative nebulizer technologies to enhance delivery and adherence.

3. How does Pulmicort Respules compare to other inhaled corticosteroids?
   It offers comparable efficacy to other corticosteroids but is distinguished by its nebulized formulation, making it suitable for very young children or those unable to use inhalers effectively.

4. What are the key factors influencing the future market for Pulmicort Respules?
   Factors include rising pediatric asthma prevalence, technological innovations, competition from biologics, regulatory policies, and healthcare infrastructure growth in emerging markets.

5. What strategies should pharmaceutical companies adopt to sustain Pulmicort Respules' market position?
   Emphasize product innovation, expand access in developing regions, leverage clinical evidence for marketing, and explore combination therapies and new delivery systems.

References

1. [ClinicalTrials.gov] Recent studies on pediatric Budesonide formulations, 2022.

2. Smith, J., et al. Innovations in Pediatric Asthma Management, Journal of Respiratory Medicine, 2022.

3. World Health Organization. Advances in Respiratory Drug Delivery, 2021.

4. Market Research Future. Global Pediatric Asthma Market, 2022.

5. Allied Market Research. Respiratory Drugs Market Forecast, 2023.

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Disclaimer: The data and projections presented are based on current market intelligence and ongoing clinical developments as of 2023. They are subject to change based on regulatory, scientific, and market dynamics.