CLINICAL TRIALS PROFILE FOR PULMICORT FLEXHALER

All Clinical Trials for Pulmicort Flexhaler

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00702325 ↗	Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans	Completed	AstraZeneca	Phase 4	2008-06-01	To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.
NCT01218399 ↗	Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations	Completed	AstraZeneca	N/A	2009-09-01	This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with Stanford staff. We hypothesize that the budesonide/formoterol combination improves the efficacy of budesonide alone.
NCT01218399 ↗	Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations	Completed	Stanford University	N/A	2009-09-01	This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with Stanford staff. We hypothesize that the budesonide/formoterol combination improves the efficacy of budesonide alone.
NCT01219738 ↗	Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide	Completed	AstraZeneca	N/A	2008-07-01	Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g. locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists (e.g. inhaled beta-adrenergic agonists).
NCT01219738 ↗	Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide	Completed	University of Miami	N/A	2008-07-01	Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g. locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists (e.g. inhaled beta-adrenergic agonists).
NCT01520688 ↗	Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth	Completed	West Penn Allegheny Health System	Phase 4	2012-02-01	Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids.

Clinical Trial Conditions for Pulmicort Flexhaler

Condition Name

Condition Name for Pulmicort Flexhaler
Intervention	Trials
Asthma	4
Osteoporosis	1
Relative Bioavailability	1

Condition MeSH

Condition MeSH for Pulmicort Flexhaler
Intervention	Trials
Asthma	4
Osteoporosis	1

Clinical Trial Locations for Pulmicort Flexhaler

Trials by Country

Trials by Country for Pulmicort Flexhaler
Location	Trials
United States	27

Trials by US State

Trials by US State for Pulmicort Flexhaler
Location	Trials
New York	2
Maryland	2
Florida	2
California	2
Pennsylvania	2

Clinical Trial Progress for Pulmicort Flexhaler

Clinical Trial Phase

Clinical Trial Phase for Pulmicort Flexhaler
Clinical Trial Phase	Trials
Phase 4	3
Phase 1	1
N/A	2

Clinical Trial Status

Clinical Trial Status for Pulmicort Flexhaler
Clinical Trial Phase	Trials
Completed	5
Withdrawn	1

Clinical Trial Sponsors for Pulmicort Flexhaler

Sponsor Name

Sponsor Name for Pulmicort Flexhaler
Sponsor	Trials
AstraZeneca	4
Stanford University	1
University of Miami	1

Sponsor Type

Sponsor Type for Pulmicort Flexhaler
Sponsor	Trials
Industry	4
Other	4

PULMICORT FLEXHALER: Clinical Trials, Market Analysis, and Projections

Clinical Trials Overview

Adult Patients with Asthma

PULMICORT FLEXHALER has been extensively tested in clinical trials to evaluate its efficacy and safety in adult patients with mild to moderate asthma. In one key study, 621 patients aged 18 to 80 years, whose symptoms were previously controlled on inhaled corticosteroids, were enrolled. The study involved administering PULMICORT FLEXHALER 180 mcg twice daily. The results showed a significant improvement in lung function, with a mean change from baseline in FEV1 (Forced Expiratory Volume in 1 second) of 0.28 liters compared to 0.10 liters in the placebo group (p < 0.001)[1].

Pediatric and Adolescent Patients with Asthma

In another study, 516 pediatric and adolescent patients aged 6 to 17 years with mild asthma were treated with PULMICORT FLEXHALER. The treatment group received 90 mcg, 4 inhalations twice daily. The results indicated a mean change from baseline in % predicted FEV1 of 5.6 compared to 0.2 in the placebo group (p < 0.001). This study also showed improvements in secondary endpoints such as morning and evening peak expiratory flow rates and asthma symptom severity[1].

Adverse Reactions and Safety

Clinical trials have also highlighted common adverse reactions associated with PULMICORT FLEXHALER, including localized infections with Candida albicans in the mouth and pharynx. The incidence of these adverse reactions was observed in pooled data from two double-blind, placebo-controlled clinical trials involving 226 patients[4].

Market Analysis

Global Market Trends

The global budesonide inhaler market, which includes PULMICORT FLEXHALER, is projected to experience significant growth. As of 2017, the market was valued at US$ 5.25 billion and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 5.8% from 2018 to 2026. This growth is driven by increasing launches of generic versions of budesonide and the rising incidence of asthma and Chronic Obstructive Pulmonary Disease (COPD)[2].

Regional Market Performance

The Asia Pacific region is anticipated to show substantial growth in the budesonide inhaler market, driven by the presence of major pharmaceutical companies in emerging economies such as China, India, and Japan. Companies like Cipla Limited, Lupin Limited, and Takeda Pharmaceutical Company Ltd. are key players in this region[2].

Market Segmentation

The asthma treatment market, which includes PULMICORT FLEXHALER, is segmented by route of administration. The inhalation segment, where PULMICORT FLEXHALER is categorized, is expected to dominate due to the significant number of products administered through this route. Other segments include injectable and oral, with the injectable segment anticipated to grow due to the increasing use of immunomodulators[3].

Market Projections

Growth Drivers

The growth of the budesonide inhaler market, including PULMICORT FLEXHALER, is driven by several factors:

• Increasing Incidence of Asthma and COPD: According to the Centers for Disease Control and Prevention (CDC), over 26 million people in the U.S. have asthma, contributing to the demand for effective treatments like budesonide inhalers[2].
• Launch of Generic Versions: The introduction of generic versions of budesonide, such as the one launched by Lupin in November 2018, is expected to increase market accessibility and affordability[2].
• Advanced Therapeutics: Ongoing research and development for advanced asthma therapeutics, including pipeline candidates in various stages of clinical trials, are projected to further propel market growth[3].

Regional Growth

The Asia Pacific region is expected to be a significant contributor to the market growth, driven by the large and underpenetrated market in countries like China and India. The rest of the world, including Latin America and the Middle East & Africa, is also expected to see growth due to the increasing prevalence of chronic respiratory diseases and the launch of key products[3].

Key Takeaways

• Clinical Efficacy: PULMICORT FLEXHALER has demonstrated significant improvements in lung function and asthma symptom severity in both adult and pediatric patients.
• Market Growth: The global budesonide inhaler market is projected to grow at a CAGR of 5.8% from 2018 to 2026, driven by increasing incidence of asthma and COPD, and the launch of generic versions.
• Regional Performance: The Asia Pacific region is expected to be a key driver of market growth due to the presence of major pharmaceutical companies and a large underpenetrated market.
• Safety and Adverse Reactions: Clinical trials have identified localized infections with Candida albicans as a common adverse reaction, emphasizing the need for proper patient education and use.

FAQs

What is PULMICORT FLEXHALER used for?

PULMICORT FLEXHALER is used for the treatment of mild to moderate asthma in patients aged 6 years and older.

How is PULMICORT FLEXHALER administered?

PULMICORT FLEXHALER is administered via inhalation, with the dose dependent on airflow through the device. It is available in 90 mcg and 180 mcg strengths.

What are the common adverse reactions associated with PULMICORT FLEXHALER?

Common adverse reactions include localized infections with Candida albicans in the mouth and pharynx.

What is the projected growth rate of the budesonide inhaler market?

The global budesonide inhaler market is projected to exhibit a CAGR of 5.8% from 2018 to 2026.

Which region is expected to drive the growth of the budesonide inhaler market?

The Asia Pacific region is expected to be a significant driver of market growth due to the presence of major pharmaceutical companies and a large underpenetrated market.

Sources

1. PULMICORT FLEXHALER label - accessdata.fda.gov
2. Global Budesonide Inhaler Market to Surpass US$ 8.24 Billion by 2026 - GlobeNewswire
3. Asthma Treatment Market Size, Share, Growth | Global Report, 2032 - Fortune Business Insights
4. PULMICORT FLEXHALER - accessdata.fda.gov