CLINICAL TRIALS PROFILE FOR ALBUTEROL

505(b)(2) Clinical Trials for albuterol

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.

All Clinical Trials for albuterol

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.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000578 ↗	NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1994-04-01	To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.
NCT00000578 ↗	NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1994-04-01	To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.

Clinical Trial Conditions for albuterol

Condition Name

Condition Name for albuterol
Intervention	Trials
Asthma	147
Pulmonary Disease, Chronic Obstructive	30
COPD	15
Chronic Obstructive Pulmonary Disease	12

Condition MeSH

Condition MeSH for albuterol
Intervention	Trials
Asthma	153
Lung Diseases	56
Pulmonary Disease, Chronic Obstructive	52
Lung Diseases, Obstructive	36

Clinical Trial Locations for albuterol

Trials by Country

Trials by Country for albuterol
Location	Trials
Germany	111
China	55
Canada	43
Mexico	43
Argentina	38

Trials by US State

Trials by US State for albuterol
Location	Trials
California	102
Florida	77
Texas	77
North Carolina	73
Missouri	66

Clinical Trial Progress for albuterol

Clinical Trial Phase

Clinical Trial Phase for albuterol
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	5
PHASE2	2

Clinical Trial Status

Clinical Trial Status for albuterol
Clinical Trial Phase	Trials
Completed	200
Terminated	22
Recruiting	19

Clinical Trial Sponsors for albuterol

Sponsor Name

Sponsor Name for albuterol
Sponsor	Trials
GlaxoSmithKline	43
Teva Branded Pharmaceutical Products R&D, Inc.	30
National Heart, Lung, and Blood Institute (NHLBI)	22

Sponsor Type

Sponsor Type for albuterol
Sponsor	Trials
Other	231
Industry	206
NIH	31

Albuterol: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 23, 2026

What is albuterol’s current clinical trial footprint?

Albuterol is an established short-acting beta-2 agonist (SABA) used for relief of bronchospasm in asthma and COPD. Publicly accessible trial activity for “albuterol” is ongoing but is dominated by incremental studies (formulation, delivery, pediatric use, pharmacokinetics, and comparative bronchodilation endpoints) rather than new mechanism programs.

Clinical trial activity signals (public registers):

• ClinicalTrials.gov contains active and recruiting records where “albuterol” appears as an investigational product (including inhaled and combination delivery formats).
• The trial mix is typically oriented toward device performance (e.g., metered dose inhaler, nebulizer workflow, spacer/adapter comparisons), dose regimens, or switching studies rather than disease-modifying endpoints.
• Regulatory focus for this molecule class is commonly framed around rapid onset, symptom relief, peak bronchodilation, and safety across age groups.

Practical takeaway for investors/R&D planners: the highest-probability opportunities for generating meaningful incremental value in albuterol are tied to formulation and delivery differentiation plus responder-relevant endpoints (time to onset, rescue use reduction as feasible within trial design constraints), not mechanism innovation.

Which albuterol products dominate use and procurement?

Albuterol has broad market penetration through generic and brand families across:

• Metered dose inhalers (MDIs) (e.g., albuterol sulfate)
• Nebulized solutions
• Dry powder or other inhaler formats in certain geographies
• Combination inhalers where an SABA is paired with other actives (product-specific, varies by country)

In most large markets, generic albuterol is the volume driver. Brand value is largely sustained by differentiated delivery devices, supply chain reliability, and contracted formulary positions.

What market segments generate demand?

Demand is driven by four primary use patterns:

1. Asthma rescue/reliever use
2. COPD acute symptom management
3. Emergency and urgent care settings (MDI with spacer, nebulization)
4. Hospital inpatient use (bronchospasm treatment protocols)

Procurement patterns tend to favor:

• low unit cost for generic products,
• dependable availability,
• consistent dosing delivery,
• and adherence to substitution policies.

What are the market drivers that support near-term revenue?

Key demand supports for albuterol include:

• Persistently high prevalence of asthma and COPD in treated populations (plus ongoing diagnosis rates).
• Ongoing use as first-line rescue therapy.
• Healthcare system reliance on SABA pathways for acute bronchospasm.

Regulatory and payer dynamics: Formularies and substitution policies in major markets typically maintain access because albuterol is inexpensive relative to controller therapies and is included in standard care pathways.

What is the market structure and pricing pressure?

Albuterol’s market is characterized by:

• Generic competition across inhaled forms
• frequent tender-driven pricing in public systems
• brand switching limited mostly by device performance or supply contracts
• high sensitivity to raw material and manufacturing capacity

The result is typically:

• lower gross pricing power,
• but stable base demand from chronic disease burden and emergency use.

How big is the albuterol market and what does the projection imply?

A precise single-number “albuterol market size” varies by source because:

• some reports model “inhaled bronchodilators” as a category that includes multiple actives,
• some include combinations,
• others isolate albuterol-only.

The most actionable approach for projection is to model albuterol’s outlook as a function of:

• patient base and acute exacerbation volumes,
• SABA guideline adherence patterns,
• and share retention among generic and branded delivery variants.

Projection logic (base case):

• Volume is relatively stable and supported by asthma/COPD prevalence.
• Value growth is constrained by generic pricing pressure.
• Upside can come from:
  • pediatric and device-optimized formulations,
  • contracted supply and market share gains,
  • and replacement of less convenient delivery options with inhalation devices that improve usability/adherence.

Projection direction: modest nominal growth is more plausible than high-growth behavior for albuterol absent major changes in guideline standards or patent-protected differentiation.

How do clinical trial updates translate into market impact?

Even when trials run continuously, market impact usually requires:

• a regulatory label expansion that changes patient identification or dosing,
• a device change that materially improves usability and adherence,
• or a combination product that alters positioning.

Albuterol’s clinical trial activity tends to be valuable for:

• expanding age-appropriate dosing,
• ensuring comparable efficacy across devices,
• and maintaining market access under post-approval requirements.

Representative clinical endpoint patterns used in albuterol trials

Studies commonly use endpoints such as:

• time to onset of bronchodilation,
• peak expiratory flow or FEV1 improvements,
• symptom score changes,
• rescue medication frequency,
• adverse event rates (tremor, tachycardia, hypokalemia signals).

What are the biggest near-term risks to albuterol forecasts?

1. Generic price compression driven by additional entrants and tender dynamics.
2. Guideline-driven behavior shifts where treatment algorithms reduce reliance on SABA alone in favor of controller-based strategies for some asthma phenotypes.
3. Supply chain fragility (API availability, inhaler component sourcing).
4. Competition from alternative reliever options and newer rescue pathways in markets where they gain formulary access.

What is the biggest upside for albuterol-focused R&D?

The most investable differentiation themes are:

• Delivery system optimization that improves inhalation technique usability and reduces dosing errors.
• Formulation improvements that enable consistent spray characteristics or nebulization performance.
• Pediatric-focused dosing and usability (device fit, spacer compatibility, simplified administration).
• Comparative effectiveness designs that validate real-world adherence proxies using device-centric endpoints.

How does patent and regulatory status affect the outlook?

Albuterol’s core molecule is widely off-patent in most jurisdictions. Market participation is largely governed by:

• formulation/device patents (where present),
• regulatory exclusivity for specific products in certain geographies,
• and manufacturing authorization and labeling differentiation.

This drives a business reality: most new entrants win by execution and access strategy rather than new mechanism claims.

Clinical trials update: what to watch next

For decision-grade monitoring, track:

• trial recruitment status changes on ClinicalTrials.gov for albuterol-containing interventional studies,
• label-related postings (if any) linked to approved formulations or devices,
• and trial endpoint types that align with procurement and payer decision-making (time-to-onset, rescue utilization, pediatric administration success).

Market projection summary

Base case: stable demand anchored to asthma/COPD prevalence and rescue pathway persistence, with modest value growth limited by generic pricing.

Upside case: faster adoption of differentiated delivery formats and sustained formulary share via device performance claims supported by clinical data.

Downside case: continued generic price erosion plus payer and guideline shifts that reduce SABA-only patterns in certain segments.

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Key Takeaways

• Albuterol’s clinical trial activity is persistent but is dominated by incremental delivery/formulation studies rather than new mechanism advances.
• Market demand is anchored to asthma and COPD rescue use, emergency care protocols, and inpatient bronchospasm pathways.
• Forecasts are constrained by generic competition and tender-driven pricing, supporting stable-to-modest growth rather than high expansion.
• The most practical R&D value creation comes from device and formulation differentiation tied to endpoints relevant to real-world administration and bronchodilation speed.

FAQs

1. Is albuterol still being tested in clinical trials?
   Yes. Public trial registries show ongoing interventional studies involving albuterol, typically focused on formulations, delivery devices, dosing regimens, and population subsets.

2. What endpoints matter most in albuterol trials for market relevance?
   Time to onset of bronchodilation, peak lung function metrics (e.g., FEV1/PEF), symptom improvement, rescue medication patterns, and adverse event profiling.

3. What drives albuterol revenue growth most in the real world?
   Formulary access, procurement contracts, and device/formulation differentiation that improves usability and adherence in treated populations.

4. How does generic competition shape pricing and projections?
   Generic entry and tender dynamics typically compress unit pricing, making revenue growth largely dependent on volume stability and share retention.

5. Where are the most plausible R&D opportunities for albuterol-related programs?
   Delivery system improvements, pediatric usability and dosing optimization, and product designs that can demonstrate consistent bronchodilation with practical administration advantages.

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References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
[2] FDA. (n.d.). Drugs@FDA: albuterol-related drug labeling and reviews. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] World Health Organization. (n.d.). Asthma and COPD resources and treatment pathway guidance. https://www.who.int/health-topics/respiratory-conditions