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.
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

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.
NCT00320034 ↗	Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma	Completed	Sunovion	Phase 2	2006-04-01	The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol. R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients. However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways. The purpose of this study is to compare the effects of the R- and S- isomers on allergen induced airway inflammation in subjects with mild atopic asthma. This will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.

Clinical Trial Conditions for VENTOLIN

Condition Name

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

Condition MeSH

Condition MeSH for VENTOLIN
Intervention	Trials
Asthma	23
Pulmonary Disease, Chronic Obstructive	5
Lung Diseases, Obstructive	4
Lung Diseases	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
Florida	3
California	3
Texas	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
ALK-Abelló A/S	2

Sponsor Type

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

Ventolin (albuterol) Clinical Trials Update, Market Analysis, and Launch/Patent Projection

Last updated: May 26, 2026

Ventolin’s commercial profile is driven by long-standing inhaled albuterol sulfate demand and the pace of generic and authorized generic uptake rather than new innovation. Clinical-trial activity remains mostly incremental (device, formulation, dosing regimens) and is unlikely to shift the long-term market structure. Near- to mid-term revenue exposure sits with the remaining brand share in the US and select ex-US markets where reimbursement and channel contracting delay generic substitution.

What clinical trials are happening for Ventolin (albuterol) right now?

Clinical development for Ventolin and other albuterol sulfate metered-dose inhalers (MDIs) clusters around:

• Comparative efficacy and safety versus other short-acting beta-agonists (SABAs)
• Inhalation technique adherence programs and real-world endpoints
• Device-drug performance equivalence (actuator, plume geometry, internal suspension stability)
• Transition studies tied to propellant and device ecosystem updates

Are Ventolin trials focused on new indications or label expansion?

Most current and recent albuterol programs are not broad “new indication” efforts. Trial designs typically support:

• Pediatric usability and inhalation technique endpoints
• Rescue use endpoints (symptom score, rescue-free interval in acute episodes)
• Pharmacodynamic measures (bronchodilation kinetics) that are often used for regulatory bridging in combination products and device updates

What types of trials have the highest likelihood of changing Ventolin’s competitive position?

Those most likely to affect market uptake are not “efficacy invention” trials but regulatory and formulation work that can:

• Enable additional product configurations that compete with branded differentiation
• Support switching to equivalent generic substitutes faster by reducing perceived performance gaps
• Improve patient usability via device iteration that can matter in competitive tenders

Which clinical studies underpin Ventolin’s regulatory standing and ongoing product life cycle?

Ventolin’s core active ingredient, albuterol sulfate, is established. Ongoing work is usually used to maintain product quality, meet post-approval requirements, and support manufacturing or device changes.

What endpoints matter in albuterol MDI trials?

Commonly used endpoints include:

• Time to bronchodilation or change in FEV1/peak flow measures
• Symptom relief scores and rescue medication use
• Inhalation technique performance and user error rates
• Safety endpoints focused on beta-agonist class effects (tachycardia, tremor)

What population focus appears most often?

• Pediatric and adolescent subsets for usability and coordination feasibility
• Acute rescue presentations
• Patients transitioning between inhaler types (propellant or actuator changes)

What is the Ventolin market size and share trajectory in the US?

Ventolin faces a structurally mature market with widespread generic availability. The market’s growth rate tends to track:

• Asthma and COPD prevalence dynamics
• SABA prescribing patterns (including guideline-driven emphasis shifts)
• Payer formularies and step therapy policies
• Switches to alternative bronchodilators where clinically appropriate

Market drivers

• Stable baseline demand due to acute rescue need
• Ongoing generic substitution that compresses net price
• Reimbursement and pharmacy benefit design that favors lower-cost equivalents
• Patient adherence effects: usability of delivered dose matters, which can temporarily protect share for better-performing devices

Market headwinds

• Patent and exclusivity are not the main constraint because albuterol’s active ingredient is long off innovation protection in most jurisdictions
• Regulatory and payer pressure to reduce pharmacy spend supports rapid generic switching
• Competitors also include alternative SABA delivery formats beyond MDIs, including nebulizers and dry powder inhalers where covered

How does Ventolin compare with other albuterol brands and authorized generics?

Ventolin competes with:

• Generic albuterol sulfate MDIs
• Authorized generics (where applicable through branded channel contracts)
• Alternative rescue therapies (including other SABAs and combination approaches when clinically indicated)

Competitive comparison that drives net pricing

• Device usability and dose consistency can influence physician and patient preference.
• Formulary placement determines volume more than marginal efficacy differences for an established SABA.
• Net price compression is the dominant determinant of profitability given generic entry.

When does Ventolin lose exclusivity, and what does that mean for market timing?

For Ventolin as an albuterol sulfate MDI brand, the practical “exclusivity” question is less about active-ingredient patents and more about:

• Product-specific formulation/device protections (where still applicable)
• Orange Book-listed patents tied to specific Ventolin presentations
• Any remaining exclusivity for particular dosage forms or configurations

In mature SABA categories, generic entry risk is typically already realized. The near-term market impact generally comes from continuing substitution through pharmacy benefit tender cycles rather than new “entry windows.”

What Orange Book status applies to Ventolin products and how does it affect generic launch risk?

Ventolin’s US brand moat, where it still exists, would be tied to:

• Specific listed patents for particular presentations (strength, container type, device configuration)
• Exclusivity periods, if any, tied to specific approvals beyond the base active ingredient

For generic launch risk, the critical issues are:

• Whether any Orange Book-listed patents remain unexpired for the specific Ventolin NDC and dosage form
• Whether there are Paragraph IV challenges that trigger exclusivity or stay-of-generic timelines
• Whether settlement agreements delay generic launches even after patent expiration

What patent estate protects Ventolin and how strong is it versus generic threats?

For long-established drugs like albuterol, patent estates are typically:

• Limited to secondary elements like device, formulation details, and specific manufacturing methods
• Weak in the context of broad active-ingredient freedom, given widespread generic availability

The business impact is still real:

• If remaining patents exist only for certain presentations, they can create localized bottlenecks that protect brand share in specific channels
• If no enforceable patents remain, the brand’s main defense is supply continuity and contracted formulary placement

What Paragraph IV and biosimilar-style risks exist for Ventolin?

• Biosimilars do not apply to Ventolin because it is a small-molecule SABA, not a biologic.
• Paragraph IV risk exists only to the extent that Ventolin has unexpired US patents listed for specific NDCs.
• For the category, most generic substitution has already occurred, so remaining Paragraph IV activity tends to be presentation-specific and opportunistic.

What generic entry scenarios are most likely for Ventolin presentations?

For Ventolin, the realistic “generic entry scenario” is already largely the baseline. The future competitive pattern typically looks like:

• Incremental share loss from brand to generics in tenders and plan switches
• Price compression with no major clinical performance gap
• Device or device-cost changes that reduce differentiation and speed replacement

What’s the fastest path to market share loss?

• Formulary changes that remove brand coverage or add generics with lower copays
• Pharmacy benefit managers standardizing on a preferred generic MDI
• Supply-based substitution when brand inventories become constrained in channel

How do recent inhaler device trends affect Ventolin demand and substitution risk?

Inhaler ecosystems influence substitution risk through usability and patient training:

• If a competitor’s device improves actuation consistency, spacers and inhalation technique training can shift utilization
• Tender decisions often reward delivery reliability, not only drug substance cost
• Device changes can temporarily slow switching if patients resist coordination changes, but this effect typically fades after adoption cycles

What is the revenue projection for Ventolin over the next 3–5 years?

A credible projection for Ventolin hinges on:

• US and ex-US share trajectory under ongoing generic penetration
• Net price compression due to generic competition
• Any incremental mix shift to specific formulations/devices where the brand still has localized protection

Base-case commercial projection framework (market-structure-driven)

• Volume: modest growth or flat-to-slight decline depending on prescribing trends and alternative rescue adoption.
• Price: continued downward pressure with periodic step-downs tied to formulary and tender renewals.
• Mix: potential shift within albuterol product lines (MDI vs other delivery systems) based on payer coverage.

Net: revenue is expected to drift lower in the US unless localized device/formulation protections or contracted channel arrangements keep brand net pricing above a “generic parity floor.”

What market expansion opportunities exist for Ventolin outside the US?

Ex-US dynamics often differ:

• Patent and regulatory timelines can slow generic adoption in some jurisdictions
• Tendering systems and reimbursement rules shape adoption pace
• Quality perceptions and inhaler training infrastructure can affect switching rates

Still, the global pattern for mature SABA products usually trends toward:

• Greater generic penetration over time
• Continued price erosion in public and private payer systems
• Limited opportunity for sustained brand differentiation absent enforceable presentation-specific IP

What manufacturing and supply factors could change Ventolin forecasts?

Supply events can affect both revenue and market share temporarily:

• Production disruptions can shift patients to alternative SABAs covered by payers or available pharmacies
• Plant-level changes can alter cost structure, potentially forcing price changes
• Device-part supply constraints can slow brand fulfillment and expedite switching

Because albuterol MDIs are commodity-like in competitive status, supply reliability can be a meaningful short-term driver even when clinical positioning is stable.

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Key Takeaways

• Ventolin’s clinical program activity is likely incremental and centered on device/formulation performance and usability rather than major new clinical differentiation.
• The market is structurally mature with generic substitution as the primary driver of pricing and share. Competitive outcomes depend more on formulary placement, device usability, and supply continuity than on new efficacy evidence.
• Revenue direction over 3–5 years is dominated by net price compression and continued channel erosion, with any protection limited to specific presentations tied to product-level patents or negotiated channel terms.
• Biosimilar risk does not apply; generic entry risk is mainly presentation- and Orange-Book-specific.

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FAQs

1) Which albuterol delivery formats compete most directly with Ventolin MDI in formularies?
MDI generics, authorized generics, and in some plans nebulizer formulations when coverage favors them.

2) Do albuterol clinical trials typically change practice patterns or just support regulatory updates?
Most studies support regulatory bridging, device performance, or usability rather than changing guideline-based positioning.

3) What payer mechanisms accelerate switching from Ventolin to generic albuterol?
Formulary tier changes, step therapy edits, and PBM tendering that standardizes preferred generics.

4) How does inhaler technique training affect short-acting beta-agonist utilization?
Technique training can improve rescue outcomes and adherence, which can temporarily protect utilization even as drug substitution occurs.

5) What are the most likely operational risks to Ventolin supply?
Device component sourcing, actuator or canister production constraints, and manufacturing disruptions.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. (n.d.). Albuterol sulfate studies. U.S. National Library of Medicine.
3. Global Initiative for Asthma (GINA). (2024). Global Strategy for Asthma Management and Prevention.