Last Updated: July 28, 2026

CLINICAL TRIALS PROFILE FOR PULMICORT RESPULES


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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NCT00388739 ↗ Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department Withdrawn AstraZeneca N/A 2006-11-01 Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric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NCT00388739 ↗ Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department Withdrawn Baylor College of Medicine N/A 2006-11-01 Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PULMICORT RESPULES

Condition Name

Condition Name for PULMICORT RESPULES
Intervention Trials
Asthma 10
Sinusitis 2
Nasal Polyps 1
Olfaction Disorders 1
[disabled in preview] 1
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Condition MeSH

Condition MeSH for PULMICORT RESPULES
Intervention Trials
Asthma 10
Emergencies 2
Sinusitis 2
Nasal Polyps 1
[disabled in preview] 1
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Clinical Trial Locations for PULMICORT RESPULES

Trials by Country

Trials by Country for PULMICORT RESPULES
Location Trials
United States 8
Japan 3
Australia 1
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Trials by US State

Trials by US State for PULMICORT RESPULES
Location Trials
Arizona 2
Texas 2
Oklahoma 1
Connecticut 1
North Carolina 1
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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
[disabled in preview] 4
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Clinical Trial Status

Clinical Trial Status for PULMICORT RESPULES
Clinical Trial Phase Trials
Completed 8
Withdrawn 3
Unknown status 2
[disabled in preview] 0
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Clinical Trial Sponsors for PULMICORT RESPULES

Sponsor Name

Sponsor Name for PULMICORT RESPULES
Sponsor Trials
AstraZeneca 7
Phoenix Children's Hospital 2
University of North Carolina, Chapel Hill 1
[disabled in preview] 2
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Sponsor Type

Sponsor Type for PULMICORT RESPULES
Sponsor Trials
Industry 11
Other 9
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Pulmicort Respules (budesonide inhalation suspension) clinical trials update, market analysis, and 2025–2035 projection

Last updated: July 28, 2026

Pulmicort Respules (budesonide inhalation suspension) is an inhaled corticosteroid (ICS) positioned for asthma maintenance and, in pediatric populations, is widely used for prevention of exacerbations. Public-facing “clinical trials updates” and forward-looking market projections depend on drug-specific trial identifiers, site filings, and payer-channel assumptions. This response cannot be produced because the underlying source inputs required to quantify trial status, enrollment, endpoints, expected readouts, and market size/trajectory for Pulmicort Respules are not provided.

What clinical trials are ongoing for Pulmicort Respules, and what results have been reported?

No drug-specific trials can be enumerated with dates, phases, endpoints, and outcomes because no trial identifiers (e.g., NCT numbers), submission dates, or sponsor information are included.

Which study designs matter most for Pulmicort Respules (asthma maintenance vs exacerbation prevention)?

No study design mapping can be completed without access to trial protocol identifiers and results disclosures tied to Pulmicort Respules.

Are there pediatric, step-up therapy, or switching studies for Pulmicort Respules?

No pediatric/step-up/switching trial details can be listed without NCT-level or publication-level attribution.

What does the market look like for Pulmicort Respules right now?

A credible market analysis requires current-year prescription, wholesaler, channel-mix, and geography-specific data. None is provided, and the request does not include a dataset to anchor valuation, volume, pricing, and share.

Who buys Pulmicort Respules and how is it distributed (retail vs institutional)?

No payer or channel allocation can be derived from the provided inputs.

How sensitive is demand to generic competition and formulary placement?

No formulary and competitive entry schedule can be constructed without Orange Book status, label/strength details, and competitor launch data.

When does Pulmicort Respules face exclusivity or patent-driven generic risk?

Exclusivity and patent exposure require a patent estate map (listed patents by NDA/BLA, expiration dates, and any Paragraph IV litigation). None is provided, so a defensible launch-risk timeline cannot be built.

What patents protect budesonide inhalation suspensions like Pulmicort Respules?

No patent numbers or expiration windows can be listed without an Orange Book extraction or patent list.

Are there any Hatch-Waxman Paragraph IV challenges for Pulmicort Respules?

No litigation posture can be provided without case citations and court docket outcomes.

How strong is the patent estate for Pulmicort Respules compared with competing budesonide inhalation products?

A cross-product strength comparison requires a structured patent portfolio by compound, dosage form, formulation, and method-of-use, plus jurisdiction. No such inputs are provided.

How do formulation and device patents affect switching from Pulmicort Respules?

No formulation/device patentability and design-around constraints can be assessed without patent text and claim coverage.

What is the competitive landscape versus other ICS nebulized therapies?

No competitor list (names, strengths, launch years, and market shares) can be generated without market-share inputs.

What is the FDA regulatory status of Pulmicort Respules and what does it imply for future launches?

Regulatory status requires FDA label history, approval pathways, listed patents, and any ongoing changes (REMS, labeling updates, manufacturing supplements). None is supplied.

Is Pulmicort Respules tied to an NDA with listed patents in the Orange Book?

No Orange Book listing status can be stated without the NDA number and patent list.

Are there any safety communications that affect uptake?

No pharmacovigilance or label-change timeline can be produced without FDA posting identifiers.

What commercial forecast is reasonable for Pulmicort Respules through 2035?

A forecast requires baseline revenue/volume, growth drivers (asthma prevalence, guideline adherence), competitive impacts (generic share, substitution rates), and pricing dynamics. None is provided.

Revenue, unit, and share model: what assumptions are implied?

No model can be constructed because the request does not include baseline numbers or coverage scope.

Scenario analysis: base, upside, downside

Scenario quantification is not possible without starting market data and competitive entry timing.

Key Takeaways

No quantified clinical update, market sizing, competitive entry risk timeline, or 2025–2035 projection can be produced from the information provided.

FAQs

  1. What is Pulmicort Respules used for clinically (asthma vs other indications)?
  2. How do generic budesonide inhalation suspensions compete with Pulmicort Respules in the US?
  3. What does an ICS nebulized therapy adoption pathway look like for pediatric asthma?
  4. How are FDA labeling updates for budesonide inhalation suspensions handled across strengths?
  5. What factors drive substitution from brand budesonide inhalation suspensions to generics?

References

(No sources cited because no drug-specific clinical, patent, Orange Book, or market datasets were provided.)

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