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Last Updated: June 16, 2025

CLINICAL TRIALS PROFILE FOR PULMICORT


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All Clinical Trials for Pulmicort

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000575 ↗ Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed CAMP Steering Committee Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗ Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗ Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed Johns Hopkins Bloomberg School of Public Health Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00005880 ↗ Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia Completed National Cancer Institute (NCI) Phase 2 2000-07-01 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of budesonide may be an effective way to prevent bronchial dysplasia. PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of budesonide in treating former or current smokers who have bronchial dysplasia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pulmicort

Condition Name

Condition Name for Pulmicort
Intervention Trials
Asthma 42
Chronic Obstructive Pulmonary Disease 4
Respiratory Distress Syndrome 4
Chronic Rhinosinusitis (Diagnosis) 3
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Condition MeSH

Condition MeSH for Pulmicort
Intervention Trials
Asthma 45
Lung Diseases 9
Pulmonary Disease, Chronic Obstructive 6
Sinusitis 5
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Clinical Trial Locations for Pulmicort

Trials by Country

Trials by Country for Pulmicort
Location Trials
United States 49
Canada 23
Japan 21
China 21
United Kingdom 10
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Trials by US State

Trials by US State for Pulmicort
Location Trials
North Carolina 5
California 5
New York 4
Arizona 4
Pennsylvania 3
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Clinical Trial Progress for Pulmicort

Clinical Trial Phase

Clinical Trial Phase for Pulmicort
Clinical Trial Phase Trials
Phase 4 29
Phase 3 20
Phase 2/Phase 3 3
[disabled in preview] 8
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Clinical Trial Status

Clinical Trial Status for Pulmicort
Clinical Trial Phase Trials
Completed 51
Unknown status 12
Withdrawn 5
[disabled in preview] 4
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Clinical Trial Sponsors for Pulmicort

Sponsor Name

Sponsor Name for Pulmicort
Sponsor Trials
AstraZeneca 28
St. Paul's Hospital, Canada 4
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for Pulmicort
Sponsor Trials
Other 100
Industry 41
NIH 7
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Pulmicort: Clinical Trials, Market Analysis, and Projections

Introduction to Pulmicort

Pulmicort, a brand name for the medication budesonide, is a corticosteroid widely used in the treatment of asthma and other respiratory conditions. It works by reducing inflammation and swelling in the airways, helping to prevent and control symptoms such as wheezing and shortness of breath.

Clinical Trials Update

Current and Ongoing Trials

Several clinical trials are currently underway or have recently been completed to evaluate the efficacy, safety, and pharmacokinetics of Pulmicort.

Comparison of Current and New Version of Pulmicort Turbuhaler

A Phase 3 clinical trial (Study identifier: SD-004-0726) is comparing the efficacy, safety, and pharmacokinetics of the current US version of Pulmicort Turbuhaler with a new version in asthmatic children and adolescents. This double-blind, randomized study aims to assess whether the new formulation offers any advantages over the existing one[1].

Budesonide and Formoterol Fumarate Metered Dose Inhaler

Another significant trial (Study identifier: D5982C00005) is a 12-week study evaluating the efficacy and safety of a budesonide and formoterol fumarate metered dose inhaler compared to a budesonide metered dose inhaler in participants with inadequately controlled asthma. This randomized, double-blind, parallel group study is part of AstraZeneca's ongoing efforts to improve asthma treatment options[4].

Market Analysis

Global Market Overview

The global market for Pulmicort, which is essentially the market for budesonide, is substantial and growing. Here are some key points from the market analysis:

Market Size and Forecast

The global Pulmicort market was estimated to be worth millions of dollars in 2023 and is forecast to grow significantly by 2030, with a Compound Annual Growth Rate (CAGR) during the forecast period of 2024-2030[2].

Market Segmentation

The market is segmented by region, type, and application. Key regions include North America, Europe, Asia Pacific, South America, and the Middle East and Africa. By type, the market includes injectable suspension, aerosols, inhalation powder, and tablets/capsules. The primary application is in the treatment of respiratory diseases, with other applications including nose diseases and inflammatory bowel disease[2].

Competitive Landscape

The market is highly competitive, with major players such as AstraZeneca, Teva, Mylan, Sandoz, Cosmo Pharmaceuticals, and others. These companies are focusing on developing new products, expanding their geographical reach, and entering into strategic partnerships to strengthen their market position[2].

Market Trends and Drivers

Increasing Prevalence of Asthma

One of the critical drivers of the Pulmicort market is the increasing prevalence of asthma worldwide. According to the American Academy of Allergy, Asthma & Immunology (AAAAI), approximately 8.3% of children in the U.S. had asthma in 2016, highlighting the ongoing need for effective asthma treatments[3].

Advanced Therapeutics and R&D

Strong research and development (R&D) efforts by key market players are driving the development of advanced therapeutics for asthma. For instance, positive clinical developments such as the phase III IRIDIUM study of inhaled combination QVM149 by Novartis are expected to further propel the market growth[3].

Route of Administration

The inhalation segment dominates the route of administration for asthma treatments, with Pulmicort being a prominent product in this category. This segment is expected to continue its dominance due to the effectiveness of inhalation-based treatments for respiratory conditions[3].

Projections and Growth Factors

Market Growth Projections

The global budesonide market, which includes Pulmicort, is projected to grow from USD 8,731.3 million in 2025 to USD 15,208.9 million by 2033, at a CAGR of 5.6% during the forecast period. This growth is attributed to the increasing prevalence of respiratory diseases, the rising demand for minimally invasive and non-surgical treatments, and the availability of new formulations[5].

Key Growth Factors

  • Increasing Demand for Combination Therapies: The use of combination therapies, such as budesonide and formoterol fumarate, is on the rise, driving market growth.
  • Development of New Delivery Systems: Improvements in delivery systems, such as metered dose inhalers and dry powder inhalers, are enhancing patient compliance and treatment efficacy.
  • Growing Adoption of Biosimilars: The increasing adoption of biosimilars is expected to further drive the market growth by offering cost-effective alternatives to branded drugs[5].

Regional Market Analysis

Asia Pacific

The Asia Pacific region is expected to drive significant growth in the Pulmicort market, driven by a large and underpenetrated market, particularly in countries like China. Positive performance in this region, coupled with the increasing prevalence of chronic respiratory diseases, is projected to fuel market growth[3].

North America and Europe

These regions also hold significant market share due to the high prevalence of asthma and other respiratory conditions. The presence of major pharmaceutical companies and robust healthcare infrastructure in these regions supports the market growth[2].

Key Takeaways

  • Clinical Trials: Ongoing trials are focused on improving the efficacy and safety of Pulmicort formulations.
  • Market Growth: The global Pulmicort market is expected to grow significantly, driven by increasing asthma prevalence and advancements in treatment options.
  • Competitive Landscape: Major pharmaceutical companies are investing heavily in R&D and strategic partnerships to maintain market share.
  • Regional Growth: The Asia Pacific region is anticipated to be a key driver of market growth due to its large and underpenetrated market.

FAQs

What is Pulmicort used for?

Pulmicort, or budesonide, is used in the treatment of asthma and other respiratory conditions by reducing inflammation and swelling in the airways.

What are the current clinical trials for Pulmicort?

Current trials include a comparison of the current and new version of Pulmicort Turbuhaler in children and adolescents, and a study evaluating the efficacy and safety of a budesonide and formoterol fumarate metered dose inhaler.

What is the projected market size for Pulmicort by 2030?

The global Pulmicort market is forecast to grow significantly by 2030, with a projected market size in the billions of dollars.

Which regions are driving the growth of the Pulmicort market?

The Asia Pacific region, along with North America and Europe, are key drivers of the Pulmicort market growth due to their large patient populations and advanced healthcare infrastructures.

What are the major growth factors for the Pulmicort market?

Key growth factors include the increasing prevalence of respiratory diseases, advancements in treatment options, and the growing adoption of biosimilars.

Sources

  1. AstraZeneca Clinical Trials: "A Placebo-controlled comparison of the efficacy, safety and pharmacokinetics of the current US version of Pulmicort (Budesonide) Turbuhaler and the new version of Pulmicort Turbuhaler in Asthmatic children and Adolescents."
  2. QY Research: "Pulmicort - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030"
  3. Fortune Business Insights: "Asthma Treatment Market Size, Share, Growth | Global Report, 2032"
  4. AstraZeneca Clinical Trials: "A 12-week study to assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS)"
  5. Data Insights Market: "Strategic Analysis of Budesonide (BUD) Market Growth 2025-2033"
Last updated: 2025-01-03

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