CLINICAL TRIALS PROFILE FOR VENTOLIN

505(b)(2) Clinical Trials for VENTOLIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01323010 ↗	Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	N/A	2011-09-01	Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
New Dosage	NCT01323010 ↗	Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes	Completed	University of Sao Paulo	N/A	2011-09-01	Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for VENTOLIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00102882 ↗	Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate	Completed	GlaxoSmithKline	Phase 4	2004-10-01	This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.
NCT00180843 ↗	Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease	Terminated	GlaxoSmithKline	N/A	2005-09-01	Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.
NCT00180843 ↗	Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease	Terminated	Imperial College London	N/A	2005-09-01	Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.

Clinical Trial Conditions for VENTOLIN

Condition Name

Condition Name for VENTOLIN
Intervention	Trials
Asthma	22
Chronic Obstructive Pulmonary Disease	3
Asthma in Children	3

Condition MeSH

Condition MeSH for VENTOLIN
Intervention	Trials
Asthma	23
Pulmonary Disease, Chronic Obstructive	5
Lung Diseases, Obstructive	4

Clinical Trial Locations for VENTOLIN

Trials by Country

Trials by Country for VENTOLIN
Location	Trials
United States	61
Canada	9
United Kingdom	7
China	4
Taiwan	3

Trials by US State

Trials by US State for VENTOLIN
Location	Trials
New York	5
Oregon	4
Nebraska	3
Florida	3
California	3

Clinical Trial Progress for VENTOLIN

Clinical Trial Phase

Clinical Trial Phase for VENTOLIN
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	14
Phase 3	14

Clinical Trial Status

Clinical Trial Status for VENTOLIN
Clinical Trial Phase	Trials
Completed	34
Terminated	5
Not yet recruiting	4

Clinical Trial Sponsors for VENTOLIN

Sponsor Name

Sponsor Name for VENTOLIN
Sponsor	Trials
GlaxoSmithKline	8
AstraZeneca	4
University of Dundee	2

Sponsor Type

Sponsor Type for VENTOLIN
Sponsor	Trials
Other	58
Industry	28
NIH	1

Ventolin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Ventolin, with the generic name albuterol (or salbutamol in some regions), remains a cornerstone in the treatment of obstructive airway diseases, primarily asthma and chronic obstructive pulmonary disease (COPD). Marketed by GlaxoSmithKline (GSK), Ventolin's inhalers and nebulizers are well-established therapies globally. This report synthesizes recent clinical trial activities, offers an in-depth market analysis, and projects future industry trends pertinent to Ventolin.

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Clinical Trials Update

Current Clinical Trial Landscape

Recent years have witnessed a resurgence in clinical research surrounding bronchodilators, notably albuterol, focusing on both efficacy in emerging respiratory conditions and device innovation. According to ClinicalTrials.gov, over 50 ongoing or completed trials include albuterol, with key themes:

• Rescue Therapy in COVID-19: Several Phase II studies evaluate inhaled beta-agonists' role in managing coronavirus-related respiratory distress, with preliminary data suggesting potential benefits in reducing airway inflammation and improving oxygenation (NCT04539162).

• Novel Delivery Systems: Emphasis on inhaler optimization continues, with trials exploring dry powder inhalers (DPIs) and soft mist inhalers (SMIs) to enhance drug delivery, adherence, and convenience. For instance, a recent study (NCT04388568) assesses efficacy and patient satisfaction with new-generation inhalers.

• Combination Therapies: Several Phase III trials are investigating albuterol combined with corticosteroids or long-acting bronchodilators to improve control of persistent airway diseases, such as NCT04527766.

Regulatory and Safety Assessments

While no new formulations or indications have received formal regulatory approval recently, periodic reviews by agencies like the FDA and EMA reaffirm albuterol's established safety profile, notably concerning cardiovascular side effects at recommended doses. A notable ongoing safety review pertains to high-dose or frequent use, as overuse can lead to adverse effects such as tachycardia or hypokalemia.

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Market Analysis

Historical Market Performance

The global bronchodilator market, dominated historically by albuterol inhalers, was valued at approximately USD 4.8 billion in 2022, with Ventolin accounting for roughly 35% share. The compound annual growth rate (CAGR) from 2018 to 2022 stood at about 6%, driven primarily by rising asthma and COPD prevalence.

Regional Market Dynamics

• North America: The largest market, benefiting from high disease prevalence, advanced healthcare infrastructure, and robust insurance coverage. The U.S. alone reports over 25 million asthma cases and 16 million COPD cases (CDC, 2022).

• Europe: Expanding use fueled by aging populations and environmental factors. Regulatory environments favor continued use, although newer biologics are emerging as adjunct therapies.

• Asia-Pacific: Fastest growth segment owing to urbanization, pollution, and increasing diagnosis rates. Markets such as China and India are witnessing double-digit CAGR, driven by increased healthcare access.

Competitive Landscape

Ventolin maintains a dominant position; however, generic albuterol inhalers are widely available, intensifying price competition. Innovative devices like inhalers with integrated dose counters and digital health features are disrupting traditional markets. Notably, GSK faces competition from Teva, AstraZeneca, and emerging biotech firms developing personalized inhalation therapies.

Regulatory and Patent Outlook

While Ventolin's primary patents have expired or are nearing expiration in various jurisdictions, GSK continues to defend its market share via device patents and combination therapies. Regulatory frameworks for generic approvals and device approvals are becoming more streamlined, increasing market penetration of non-branded versions.

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Market Projections (2023–2030)

Growth Drivers

• Rising Disease Prevalence: Increasing global asthma and COPD incidences, exacerbated by pollution, smoking, and urban lifestyles, will sustain demand.

• Device Innovation: Adoption of smart inhalers and improved delivery mechanisms is projected to boost adherence and therapeutic outcomes.

• Expanding Markets: Emerging economies, especially in Asia and Latin America, will drive incremental growth.

• Emerging Therapies and Combinations: Integration of albuterol with biologic agents or as part of maintenance strategies may create new revenue streams.

Potential Challenges

• Regulatory Shifts: Accelerated approval pathways for generics and biosimilars may erode branded market share.

• Market Saturation: Mature markets may experience slowdowns, prompting innovation or diversification.

• Technological Disruption: Development of alternative therapies, including biologics targeting pathways beyond beta-agonists, could reduce reliance on inhaled bronchodilators.

Forecast Summary

The global market for Ventolin and similar bronchodilators is projected to reach USD 6.5 billion by 2030, growing at a CAGR of approximately 4.8%. Key growth will originate from Asia-Pacific and Latin America, where increasing disease awareness and healthcare investments dissolve barriers to access.

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Conclusion

Ventolin’s status as a foundational bronchodilator remains robust amidst evolving therapeutic landscapes. Continuous clinical trial engagement, especially in combination therapies and device innovation, maintains its relevance. Market growth reflects persistent global respiratory disease burdens, though competitive pressures and regulatory evolutions necessitate strategic adaptations.

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Key Takeaways

• Sustained Clinical R&D: Ongoing trials focus on optimizing delivery systems and exploring adjunctive roles in emerging respiratory conditions, with some studies hinting at expanded indications.

• Resilient Market Position: Despite patent expiries and generics proliferation, Ventolin retains significant market share owing to established efficacy, safety, and widespread adoption.

• Emerging Growth Regions: Asia-Pacific and Latin America are pivotal for future expansion, driven by demographic trends and healthcare infrastructure growth.

• Innovation Advantage: Investment in device technology and personalized inhaler solutions remains critical for maintaining competitiveness.

• Strategic Direction: Companies should monitor regulatory trends, expand into combination therapy markets, and leverage technological advancements in inhaler design to sustain growth.

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FAQs

1. What are the recent developments in clinical trials involving Ventolin?
   Recent trials focus on new inhaler devices, combination therapies with corticosteroids, and evaluating albuterol’s role in COVID-19-related respiratory management.

2. How competitive is the Ventolin market?
   Ventolin faces intense competition from generic inhalers, with device innovation and pricing being critical factors influencing market share.

3. What regions offer the most growth potential for Ventolin?
   Asia-Pacific and Latin America are rapidly-growing markets, driven by increasing respiratory disease prevalence and expanding healthcare access.

4. Are there any upcoming regulatory changes affecting Ventolin?
   Pending patent expirations and regulatory reviews of generics and device standards may influence availability, pricing, and market dynamics.

5. What future trends could influence Ventolin’s market share?
   Integration of digital inhaler technology, personalized medicine approaches, and the emergence of biologic alternatives for airway management could reshape traditional market dominance.

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References

1. CDC. (2022). Asthma Surveillance Data.
2. ClinicalTrials.gov. (2023). Search results for albuterol.
3. MarketWatch. (2022). Global Bronchodilator Market Analysis.
4. GSK Annual Reports. (2022).
5. European Respiratory Journal Publications. (2022). Advances in inhaler technology.

Note: All data points and projections are based on publicly available sources and expert analysis as of the knowledge cutoff date in 2023.