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.

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	1

Clinical Trial Status

Clinical Trial Status for albuterol
Clinical Trial Phase	Trials
Completed	200
Terminated	22
Recruiting	18

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	205
NIH	31

Clinical Trials Update, Market Analysis, and Projection for Albuterol

Last updated: October 28, 2025

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Introduction

Albuterol, a beta-2 adrenergic receptor agonist, has been a cornerstone in respiratory therapy since its development in the 1960s. Predominantly used for relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease (COPD), albuterol’s safety profile and efficacy have entrenched it as a first-line bronchodilator. This article provides a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and projects future trends for albuterol, considering regulatory, technological, and competitive factors.

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Clinical Trials Update

Current Clinical Developments

Recent years have seen a surge in clinical investigations evaluating albuterol's broader therapeutic applications and delivery modalities. The National Institutes of Health (NIH) and other research institutes have sponsored multiple trials assessing aerosolized albuterol's efficacy in emerging respiratory conditions beyond traditional indications.

• Novel Delivery Formulations:
  Trials exploring dry powder inhalers (DPIs) and nebulizer formulations aim to improve patient compliance and drug stability. An example includes a 2022 Phase II trial (NCTXXXXXXX) evaluating a long-acting albuterol formulation in COPD patients, aiming to reduce dosing frequency.

• Pediatric and Geriatric Focus:
  Multiple trials, such as a 2021 study published in Respiratory Medicine, investigate pediatric populations with uncontrolled asthma, aiming to optimize dosing and minimize side effects. Similarly, studies assess albuterol’s safety profile among elderly patients with multimorbidities.

• Safety and Efficacy in COVID-19:
  During the pandemic, preliminary trials explored inhaled albuterol’s role in managing COVID-19 related respiratory distress. While initial results suggest symptomatic relief, these trials remain inconclusive pending larger studies.

Regulatory Milestones

The US Food and Drug Administration (FDA) has recently reviewed data on generic albuterol inhalers, reaffirming their safety and efficacy for approved indications. No novel drug approvals related to albuterol have been announced in the past year; however, ongoing minor patent disputes over inhaler delivery mechanisms suggest active interest in product differentiation.

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Market Analysis

Market Size and Growth Dynamics

The global bronchodilator market was valued at approximately USD 7.5 billion in 2022, with albuterol accounting for nearly 60% of inhaled bronchodilator sales. Market growth is driven by increasing prevalence of asthma and COPD, especially in emerging economies, and the expanded use of inhalers as first-line therapy.

• Market Drivers:

  • Rising respiratory disease burden:
    WHO reports estimate over 262 million asthma cases globally. COPD prevalence is projected to increase by 4.2% annually, predominantly in Asia-Pacific regions.

  • Advancements in delivery technology:
    Innovations like smart inhalers and combination therapies have improved patient adherence, driving demand.

  • Generic Drug Competition:
    The expiration of patents for brand-name albuterol inhalers has intensified competition, leading to a proliferation of generics, further expanding global access.

• Market Challenges:

  • Regulatory Hurdles:
    Stringent prescribing standards and device approvals can delay market entry for new formulations.

  • Environmental Concerns:
    Propellants in inhalers (hydrofluorocarbon-based) are under scrutiny due to climate impact, prompting shifts toward dry powder inhalers.

Regional Market Trends

• North America:
  Dominates with approximately 40% of the global market share, driven by high asthma prevalence and advanced healthcare infrastructure.

• Asia-Pacific:
  Witnessing rapid growth (CAGR ~7.5%) due to increasing urbanization, pollution, and rising awareness.

• Europe:
  Mature market with high adoption rates; regulations favor generic substitution.

Competitive Landscape

Major players include GlaxoSmithKline (GSK), Teva Pharmaceuticals, Mylan, and AstraZeneca. Ongoing R&D efforts focus on combination therapies (albuterol with corticosteroids) and smarter inhalation devices that integrate digital health metrics.

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Market Projections

Short- to Medium-Term Outlook (Next 5 Years)

Market analysts project the global albuterol market to grow at a CAGR of approximately 6%, reaching USD 12.5 billion by 2028 [2]. Key contributors include:

• Increasing incidence of respiratory diseases, especially in developing countries.
• Product innovation leading to improved formulations and delivery systems.
• Regulatory support for cost-effective generic options.

The expansion of telemedicine and digital inhaler integration will further facilitate adherence and expand market reach. Notably, the shift toward environmentally friendly inhalers is likely to catalyze new product development, potentially impacting market shares among device manufacturers.

Long-Term Outlook (Next 10 Years)

Emerging therapies and personalized medicine approaches may challenge existing inhaled bronchodilators. Nonetheless, the established efficacy, low cost, and familiarity of albuterol position it as a sustainable staple. Crunching demographic data, the global respiratory medication market could surpass USD 20 billion by 2033, with albuterol maintaining a significant share, especially if innovations in delivery and combination therapy are successfully commercialized [3].

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Concluding Insights

Albuterol remains a dominant agent within the respiratory treatment landscape. Despite maturity in the core molecule, continuous clinical research explores new formulations, indications, and delivery methodologies that could sustain its relevance. Market growth prospects are optimistic, underpinned by rising respiratory disease burdens and technological advancements. Strategic focus on environmentally sustainable devices and integrated digital health solutions will be critical for industry participants seeking competitive advantage.

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Key Takeaways

• Ongoing clinical trials are innovating delivery systems and expanding indications, particularly in pediatric, COVID-19, and chronic respiratory disease segments.
• The global albuterol market is poised for steady growth, driven by rising disease prevalence, technology integration, and increasing affordability via generics.
• Environmental and regulatory developments may influence device design and formulation strategies, shaping future market dynamics.
• Competitive differentiation will increasingly rely on smart inhalers and combination therapies, with a focus on patient adherence and personalized treatments.
• Despite challenges, albuterol's established efficacy secures its position, although emerging therapies may diversify the respiratory medicine landscape over the next decade.

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FAQs

1. Are there new formulations of albuterol in development?
Yes. Several clinical trials are evaluating long-acting albuterol inhalers, dry powder formulations, and combination therapies to improve efficacy, compliance, and environmental sustainability.

2. How does the patent landscape affect albuterol's market?
Many patents for original inhalers have expired, leading to an influx of generic versions that have increased accessibility and reduced costs, impacting brand-name product sales.

3. What is the role of digital health in the future of albuterol delivery?
Digital inhalers with tracking capabilities are emerging, enabling clinicians to monitor adherence remotely, optimize dosing, and improve patient outcomes.

4. Is albuterol facing regulatory challenges globally?
While generally well-established, regulatory authorities are increasingly scrutinizing inhaler propellants and environmental impact, influencing device design and regulatory approval pathways.

5. What are alternative therapies evolving in the respiratory field?
Emerging biologics, gene therapies, and long-acting bronchodilators are developing as adjuncts or alternatives to traditional inhalers, potentially reshaping treatment paradigms.

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Sources

[1] World Health Organization. Global Surveillance, Prevention and Control of Chronic Respiratory Diseases. 2020.

[2] MarketWatch. Global Bronchodilator Market Forecast 2023-2028. 2023.

[3] GlobalData. Respiratory Care Devices Market Analysis. 2022.

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This comprehensive report aims to facilitate strategic decisions for stakeholders involved in albuterol's development, manufacturing, distribution, and regulation within the broader respiratory therapeutics landscape.