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NCT00388739 ↗	Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department	Withdrawn	AstraZeneca	N/A	2006-11-01	Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric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NCT00388739 ↗	Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department	Withdrawn	Baylor College of Medicine	N/A	2006-11-01	Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in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.
NCT00588406 ↗	Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.	Completed	Jacobi Medical Center	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.
NCT00588406 ↗	Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.	Completed	Nassau University Medical Center	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.
NCT00588406 ↗	Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.	Completed	Northwell Health	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
Paranasal Sinus Diseases	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
Jacobi Medical Center	1

Sponsor Type

Sponsor Type for PULMICORT RESPULES
Sponsor	Trials
Industry	11
Other	9

Pulmicort Respules (budesonide) | Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is Pulmicort Respules and what matters commercially

Pulmicort Respules is an inhaled corticosteroid (ICS) product containing budesonide for asthma management, delivered via nebulizer (respules). In the US, the product sits in the established inhaled anti-inflammatory category where uptake is driven by: (1) pediatric and caregiver use in nebulized therapy, (2) guideline positioning of ICS, and (3) payer preference among neb ICS options.

Commercially, the product competes in a mature segment with entrenched brands and multiple generics, which compresses pricing growth and shifts value to unit volume, contracting, and channel mix (retail vs institutional).

What is the current clinical-trials signal

A complete, current “all trials” register-based update cannot be produced from the information provided in the prompt. Without a trial-by-trial dataset (NCT numbers, statuses, enrollment, endpoints, dates) there is no defensible way to state: (a) what new studies started, (b) what trials completed or reported, or (c) what readouts change the clinical or regulatory outlook for Pulmicort Respules specifically.

Accordingly, no clinical-trials update is provided.

How does the competitive landscape shape market performance

Pulmicort Respules faces competitive pressure typical of established ICS and nebulized formulations:

• Nebulized ICS substitutes: other budesonide neb products and non-budesonide nebulized corticosteroids available by region and channel.
• Device-dependent switching: some patient populations move from nebulizers to MDIs or DPIs when device coverage improves.
• Generic penetration: budesonide formulations for asthma face generic competition in multiple markets, reducing brand elasticity.

Market performance therefore tends to track:

1. Asthma prevalence and severity mix (pediatric share matters).
2. Payer formulary behavior (preferred list placement).
3. Guideline adherence (consistent ICS use).
4. Supply stability and rebate intensity (channel economics).

What is the market size context for nebulized budesonide

No market-size figures with citations are included because no source set is provided and no external retrieval is available in this context. A defensible projection requires at minimum: baseline market size, category growth rate, TAM/SAM definitions (US-only vs global), and share assumptions. These are not available in the prompt.

Accordingly, no quantified market sizing or numeric projection is provided.

Projection framework (qualitative, decision-grade)

While numeric forecasting cannot be stated without cited baselines, a decision-grade projection can be framed around the only levers that move mature neb ICS revenue:

1) Share retention vs share erosion

• Revenue resilience comes from maintaining neb-specific share among pediatric and caregiver-administered patients.
• Revenue erosion accelerates when payers prefer lower-cost equivalents or when device switching reduces nebulizer prescriptions.

2) Contracting and rebate compression

• Mature ICS products typically show revenue growth driven by volume and net-price management rather than list price expansion.
• Stronger performance depends on staying preferred under pharmacy benefit and maintaining institutional coverage for respiratory services.

3) Product-specific switching

• Pulmicort Respules can lose momentum if competing nebulized steroid options gain formulary placement.
• Gains can come from pediatric formulary updates, step-therapy exceptions, or new education programs for nebulizer technique and adherence.

Commercial outlook: what to watch

Even without a numeric forecast, the operational KPIs that determine whether Pulmicort Respules grows, stabilizes, or declines are clear:

• Nebulized ICS script trends (overall category volume)
• Net pricing (rebates, chargebacks, payer mix)
• Pediatric and Medicaid share changes (higher unit sensitivity)
• Formulary status changes (preferred vs non-preferred)
• Institutional utilization (ER and inpatient respiratory pathways)

Key takeaways

• Pulmicort Respules is a mature nebulized budesonide ICS product whose commercial outcomes are dominated by formulary positioning, generic pressure, and nebulizer-to-device switching.
• A complete clinical-trials update for Pulmicort Respules cannot be produced from the prompt’s information.
• A quantified market analysis and numerical projection cannot be produced without cited baseline market data and trial-level updates.

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FAQs

1) Is Pulmicort Respules a controller or rescue therapy?

Pulmicort Respules is an inhaled corticosteroid controller therapy used to reduce airway inflammation in asthma management rather than as an acute rescue medicine.

2) Who typically uses Pulmicort Respules?

It is commonly used in pediatric and caregiver-administered settings where nebulization is preferred or required.

3) What drives revenue for nebulized ICS products like Pulmicort Respules?

Formulary status, net pricing via rebates, pediatric share, and the extent of switching away from nebulizers.

4) What would signal clinical or regulatory headwinds for Pulmicort Respules?

Negative safety signals, guideline displacement of nebulized ICS, or trial readouts that materially change comparative efficacy against alternatives.

5) What would signal upside for Pulmicort Respules?

Gaining or maintaining preferred formulary placement, stable net pricing, and sustained nebulizer utilization in pediatric respiratory care.

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References

[1] No sources were provided in the prompt, and no external retrieval was performed in this response.