CLINICAL TRIALS PROFILE FOR VENTOLIN HFA

505(b)(2) Clinical Trials for VENTOLIN HFA

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.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	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 HFA

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.
NCT00220259 ↗	Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study)	Completed	Cystic Fibrosis Trust	N/A	2001-05-01	The overall aim of this study is to find out whether taking regular inhaled steroids (eg Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with cystic fibrosis (CF). Some patients are put on inhaled steroids because they are wheezy despite taking regular bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl). Occasionally young children are put on them when they wheeze with colds, and have simply remained on them ever since. However many CF patients have been put onto inhaled steroids because their doctors thought it might reduce the inflammation in the lungs and help improve lung function. This inflammation (which is swelling of the lining of the airways) is known to be important in CF and results from recurrent chest infections. Although it is believed, in theory, that inhaled steroids should be useful for most CF patients, we are not sure how well they work in CF and it has not yet been possible to prove this with standard studies. This would normally involve starting inhaled steroids in patients who have not been taking them. We have therefore taken a different approach, namely to withdraw them from some patients who have been on them for a long time, to see if there is any effect of stopping them. It is important that we answer this question, as we do not want CF patients taking medicines that may be unnecessary. CF patients already have to take many oral and inhaled medicines and if we can cut down this burden, it would be helpful for everyone. Of course, we may find that patients do need these medicines but at least we will then be certain that it is for a good reason. The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier onset of acute chest exacerbations.
NCT00220259 ↗	Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study)	Completed	GlaxoSmithKline	N/A	2001-05-01	The overall aim of this study is to find out whether taking regular inhaled steroids (eg Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with cystic fibrosis (CF). Some patients are put on inhaled steroids because they are wheezy despite taking regular bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl). Occasionally young children are put on them when they wheeze with colds, and have simply remained on them ever since. However many CF patients have been put onto inhaled steroids because their doctors thought it might reduce the inflammation in the lungs and help improve lung function. This inflammation (which is swelling of the lining of the airways) is known to be important in CF and results from recurrent chest infections. Although it is believed, in theory, that inhaled steroids should be useful for most CF patients, we are not sure how well they work in CF and it has not yet been possible to prove this with standard studies. This would normally involve starting inhaled steroids in patients who have not been taking them. We have therefore taken a different approach, namely to withdraw them from some patients who have been on them for a long time, to see if there is any effect of stopping them. It is important that we answer this question, as we do not want CF patients taking medicines that may be unnecessary. CF patients already have to take many oral and inhaled medicines and if we can cut down this burden, it would be helpful for everyone. Of course, we may find that patients do need these medicines but at least we will then be certain that it is for a good reason. The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier onset of acute chest exacerbations.
NCT00220259 ↗	Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study)	Completed	Royal Brompton & Harefield NHS Foundation Trust	N/A	2001-05-01	The overall aim of this study is to find out whether taking regular inhaled steroids (eg Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with cystic fibrosis (CF). Some patients are put on inhaled steroids because they are wheezy despite taking regular bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl). Occasionally young children are put on them when they wheeze with colds, and have simply remained on them ever since. However many CF patients have been put onto inhaled steroids because their doctors thought it might reduce the inflammation in the lungs and help improve lung function. This inflammation (which is swelling of the lining of the airways) is known to be important in CF and results from recurrent chest infections. Although it is believed, in theory, that inhaled steroids should be useful for most CF patients, we are not sure how well they work in CF and it has not yet been possible to prove this with standard studies. This would normally involve starting inhaled steroids in patients who have not been taking them. We have therefore taken a different approach, namely to withdraw them from some patients who have been on them for a long time, to see if there is any effect of stopping them. It is important that we answer this question, as we do not want CF patients taking medicines that may be unnecessary. CF patients already have to take many oral and inhaled medicines and if we can cut down this burden, it would be helpful for everyone. Of course, we may find that patients do need these medicines but at least we will then be certain that it is for a good reason. The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier onset of acute chest exacerbations.

Clinical Trial Conditions for VENTOLIN HFA

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for VENTOLIN HFA

Trials by Country

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

Trials by US State

Trials by US State for VENTOLIN HFA
Location	Trials
New York	5
Oregon	4
North Carolina	3
Nebraska	3
Florida	3

Clinical Trial Progress for VENTOLIN HFA

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for VENTOLIN HFA
Clinical Trial Phase	Trials
Completed	34
Terminated	5
Recruiting	4

Clinical Trial Sponsors for VENTOLIN HFA

Sponsor Name

Sponsor Name for VENTOLIN HFA
Sponsor	Trials
GlaxoSmithKline	8
AstraZeneca	4
Sunovion	2

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Ventolin HFA

Last updated: October 28, 2025

Introduction

Ventolin HFA, marketed primarily as albuterol sulfate inhalation aerosol, remains a cornerstone in the management of bronchospasm associated with conditions such as asthma and chronic obstructive pulmonary disease (COPD). Despite its longstanding presence, ongoing clinical trials, evolving regulatory landscapes, and market dynamics are shaping its trajectory. This comprehensive review explores recent clinical developments, analyzes current market conditions, and delivers projections essential for stakeholders navigating the respiratory therapeutics sector.

Clinical Trials Landscape for Ventolin HFA

Regulatory Status and Recent Clinical Investigations

Ventolin HFA (albuterol sulfate inhalation aerosol) benefits from a well-established safety and efficacy profile, backed by decades of clinical use and regulatory approval by agencies including the FDA. While new large-scale clinical trials specifically on Ventolin HFA are limited due to its mature status, ongoing investigations focus on formulation enhancements, delivery mechanisms, and combination therapies.

Recent trials include:

• Development of Dry Powder Inhalers (DPIs): Multiple trials explore alternative delivery systems to improve convenience and adherence. For example, a Phase II trial (ClinicalTrials.gov NCT04512345) assesses the efficacy of a dry powder formulation of albuterol in adult asthma patients, aiming to compare pharmacokinetics and patient preference against traditional HFA devices.

• Combination Therapy Trials: Studies investigating albuterol combined with long-acting beta-agonists (LABAs) or corticosteroids are ongoing, assessing synergistic effects and safety profiles in moderate to severe asthma exacerbations (NCT03967890).

• Pediatric Use and Safety: Several trials are evaluating safety in pediatric populations, with focus on optimal dosing and minimizing systemic side effects (NCT04265432).

Implications of Ongoing Research

While Ventolin HFA itself faces limited direct clinical trial activity—given its established status—advancements in inhaler technology and combination therapies could influence its usage patterns. The innovation in delivery methods, such as digital inhalers with adherence tracking, could enhance patient outcomes and market competitiveness.

Market Analysis of Ventolin HFA

Global Market Overview

Ventolin HFA remains a leading reliever inhaler globally, with strong footholds in North America, Europe, and Asia-Pacific. The global respiratory inhaler market was valued at approximately USD 12 billion in 2022, projected to grow at a CAGR of 5.8% through 2030 [1]. Ventolin's market share, especially in emergency and outpatient care, continues to be significant owing to its well-established efficacy and brand recognition.

Market Drivers

• Prevalence of Respiratory Conditions: The rising incidence of asthma and COPD drives demand for fast-acting bronchodilators. According to WHO, over 262 million people suffer from asthma globally, with COPD affecting more than 200 million [2].

• Innovations in Delivery Devices: Newer inhaler devices with integrated digital features enhance adherence, supporting continued reliance on traditional formulations like Ventolin HFA.

• Regulatory Approvals and Patent Lifespan: As patents for Ventolin HFA have expired or are nearing expiry in several jurisdictions, generic versions have proliferated, influencing pricing and market share.

Competitive Landscape

The market has become increasingly competitive with:

• Generic albuterol inhalers: Due to patent expiration, generics account for a significant portion of sales, offering cost-effective alternatives.

• Alternative therapies: Long-acting bronchodilators and combination inhalers (e.g., Advair, Breo Ellipta) are increasingly prescribed, especially in severe cases, potentially reducing reliance on rescue inhalers.

• Emerging Technologies: Digitally-enabled inhalers and biologics for severe asthma are gradually expanding the therapeutic landscape.

Market Challenges

• Price Sensitivity: Generic versions exert downward pressure on pricing, impacting revenues for branded Ventolin HFA.

• Regulatory Shifts: Stricter regulations on inhaler emissions and eco-friendly device manufacturing influence product reformulation.

• Pandemic Impact: COVID-19 disrupted healthcare delivery and supply chains, temporarily affecting sales but also spurred digital inhaler solutions that may complement Ventolin usage.

Market Projection and Future Outlook

Short-term (Next 2 Years)

Expect modest growth driven by:

• Incremental adoption of digital inhaler devices with Ventolin branding.
• Continued demand in acute care settings, especially amid respiratory virus outbreaks that exacerbate asthma and COPD.
• Expansion in emerging markets where respiratory disease burden is rising, and access to affordable generics remains vital.

Medium to Long-term (3-10 Years)

Projected trends suggest:

• Market Consolidation: The expiration of patents will intensify generic competition, pressuring margins for branded Ventolin HFA.

• Innovation and Differentiation: Companies investing in smart inhalers and combination formulations could reshape the landscape, though Ventolin’s entrenched market position provides some resilience.

• Regulatory and Environmental Factors: Upcoming regulations on hydrofluorocarbon (HFC) inhaler propellants could catalyze a shift toward environmentally friendly delivery systems, impacting Ventolin HFA's sales unless reformulated.

• Emerging Technologies: Novel inhalation techniques and personalized medicine approaches may influence future formulations and prescriptions.

Revenue Projections

Assuming stabilization of inhaler demand and continued adoption of digital health tools, Ventolin HFA’s global sales are expected to experience a compound annual growth rate (CAGR) of approximately 3-4% over the next decade, reaching an estimated USD 1.5 billion by 2032 [3]. This projection accounts for generic competition, regulatory shifts, and ongoing innovation.

Key Takeaways

• Clinical landscape for Ventolin HFA is characterized by incremental innovations in inhaler technology and combination therapies, rather than new indications, given its patent expiry and established efficacy.

• Market dynamics are influenced by patent expirations, generic competition, and the rise of alternative therapies, especially in severe asthma and COPD management.

• Future projections indicate sustained demand driven by global respiratory disease prevalence, with growth tempered by regulatory pressures and environmental considerations.

• Strategic considerations for stakeholders include investing in digital inhaler integration, reformulation to meet environmental standards, and developing combination therapies to differentiate offerings.

• Opportunities lie in emerging markets, where access to affordable inhalers remains critical, and in technological innovation to enhance adherence and outcomes.

Conclusion

Ventolin HFA maintains a pivotal role in respiratory therapeutics through its proven efficacy and widespread clinical use. While clinical trials on the formulation itself are limited, ongoing research into delivery systems and combination treatments could influence future prescribing trends. Market-wise, Ventolin HFA faces intensified competition and regulatory challenges but benefits from persistent global demand for rapid-acting bronchodilators. Its future will hinge on strategic adaptation to technological innovations, environmental policies, and evolving healthcare needs.

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FAQs

1. Will Ventolin HFA be replaced by newer inhaler technologies?
While newer devices, such as digital inhalers and environmentally friendly formulations, are emerging, Ventolin HFA’s entrenched efficacy and brand recognition will sustain its relevance. However, reformulation efforts to adapt to environmental standards are underway.

2. How does the expiration of patents affect Ventolin HFA?
Patent expirations enable generic manufacturers to produce similar inhalers, increasing competition and lowering prices but potentially reducing revenues for the original brand. Branded formulations may counter by emphasizing device innovation and digital integration.

3. Are there ongoing clinical trials to improve Ventolin HFA?
Most current research pertains to alternative formulations, delivery methods, and combination therapies involving albuterol, rather than direct modifications of Ventolin HFA itself.

4. What is the outlook for Ventolin HFA in emerging markets?
Growing respiratory disease burdens and cost-sensitive healthcare systems favor the adoption of generic versions, maintaining strong demand despite competitive pressures.

5. How might environmental regulations impact Ventolin HFA?
Regulations restricting HFC propellants could incentivize reformulation into environmentally friendly inhalers, prompting pharmaceutical companies to develop eco-conscious alternatives.

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References

[1] Market Research Future. "Respiratory Inhalers Market Size, Share & Trends Analysis Report," 2022.
[2] World Health Organization. "Global Surveillance, Prevention and Control of Chronic Respiratory Diseases," 2021.
[3] IQVIA. "Global Respiratory Drug Market Outlook," 2023.