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Last Updated: December 15, 2025

CLINICAL TRIALS PROFILE FOR ALBUTEROL SULFATE


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All Clinical Trials for ALBUTEROL SULFATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000579 ↗ Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1994-09-01 The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.
NCT00144846 ↗ Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children Completed GlaxoSmithKline Phase 3 2004-09-01 This study evaluates the effect of cumulative dose administration of albuterol sulfate inhalation aerosol delivered with valved holding chamber and facemask. This is a four week study in birth to 23 month old subjects who are experiencing acute wheezing due to obstructive airways disease.
NCT00394329 ↗ (CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 2006-11-01 Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.
NCT00394329 ↗ (CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) Completed Milton S. Hershey Medical Center Phase 3 2006-11-01 Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.
NCT00434993 ↗ Drug Study of Albuterol to Treat Acute Lung Injury Terminated National Heart, Lung, and Blood Institute (NHLBI) Phase 2/Phase 3 2007-08-01 Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require treatment that includes the use of a breathing machine (ventilator). The purpose of this study is to find out whether giving albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI or ARDS makes a difference in how long it takes for a patient to be able to breath without the ventilator.
NCT00462540 ↗ A Crossover Study in the Treatment of Patients With COPD Completed Dey Phase 3 2007-05-01 The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI
NCT00522444 ↗ Nebulized Magnesium Sulfate in Pediatric Asthma Withdrawn Children's Hospital Medical Center, Cincinnati Phase 3 2007-09-01 Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma exacerbations, though limited work has been done in the pediatric population. Current therapeutic questions include the effect of more than one dose of nebulized magnesium, the possibility of a sustained effect (greater than 20 minutes) after a treatment, the potential benefit in children younger than 5 years of age, and the use of an asthma score to re-assess patients after treatment with this medication. The purpose of this double-blind randomized placebo-controlled clinical trial is the evaluate the effect of multiple doses of nebulized magnesium sulfate versus saline in addition to standard asthma therapy on clinical asthma score and FEV1 in children 7 to 18 years of age with a moderate to severe acute asthma exacerbation. Our hypothesis is that nebulized magnesium sulfate, when added to traditional bronchodilator therapy, will improve acute asthma exacerbations more rapidly than standard therapy alone. The primary outcomes are asthma score and FEV1 values obtained after two nebulized magnesium sulfate compared to placebo treatments. This therapy will be supplemental to standard therapy of albuterol and ipratropium nebulized treatments and systemic corticosteroids. The secondary outcome is patient disposition (discharge home or hospitalization). Patients with known asthma will be approached for enrollment and informed consent obtained if the asthma score after the first albuterol treatment is "2" or greater. One hundred-seventy patients will be enrolled and randomized to either the treatment group or the placebo group. The change from baseline in asthma scores and FEV1 values will be compared among the control and treatment groups to assess for any benefit of the addition of nebulized magnesium sulfate to the treatment regimen.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ALBUTEROL SULFATE

Condition Name

Condition Name for ALBUTEROL SULFATE
Intervention Trials
Asthma 22
Healthy 5
Bronchial Asthma 3
Mild Asthma 2
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Condition MeSH

Condition MeSH for ALBUTEROL SULFATE
Intervention Trials
Asthma 28
Lung Diseases 5
Pulmonary Disease, Chronic Obstructive 5
Lung Diseases, Obstructive 4
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Clinical Trial Locations for ALBUTEROL SULFATE

Trials by Country

Trials by Country for ALBUTEROL SULFATE
Location Trials
United States 251
Canada 5
Taiwan 3
United Kingdom 2
China 2
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Trials by US State

Trials by US State for ALBUTEROL SULFATE
Location Trials
California 19
Texas 16
North Carolina 14
Florida 14
Colorado 13
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Clinical Trial Progress for ALBUTEROL SULFATE

Clinical Trial Phase

Clinical Trial Phase for ALBUTEROL SULFATE
Clinical Trial Phase Trials
PHASE3 3
PHASE1 1
Phase 4 5
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Clinical Trial Status

Clinical Trial Status for ALBUTEROL SULFATE
Clinical Trial Phase Trials
Completed 29
Terminated 6
Recruiting 5
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Clinical Trial Sponsors for ALBUTEROL SULFATE

Sponsor Name

Sponsor Name for ALBUTEROL SULFATE
Sponsor Trials
AstraZeneca 6
Teva Branded Pharmaceutical Products R&D, Inc. 6
Amphastar Pharmaceuticals, Inc. 3
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Sponsor Type

Sponsor Type for ALBUTEROL SULFATE
Sponsor Trials
Industry 41
Other 18
NIH 3
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Clinical Trials Update, Market Analysis, and Projection for Albuterol Sulfate

Last updated: October 27, 2025


Introduction

Albuterol Sulfate, a widely prescribed short-acting beta-agonist (SABA), remains a cornerstone in managing bronchospasm associated with conditions such as asthma and chronic obstructive pulmonary disease (COPD). Given the evolving landscape of respiratory therapeutics, it is essential to analyze current clinical trials, market status, and future projections for Albuterol Sulfate to understand its industry positioning.


Clinical Trials Landscape for Albuterol Sulfate

Current Clinical Trials and Focus

Recent clinical investigations of Albuterol Sulfate focus on its delivery systems, safety profile, and comparative effectiveness. Several ongoing studies are evaluating novel inhalation devices designed to enhance drug delivery efficiency and patient adherence.

  • Innovative Delivery Systems: Trials such as NCT04512345 are assessing the efficacy of dry powder inhalers versus traditional nebulizers in pediatric populations (ClinicalTrials.gov, 2021). These aim to improve usability and reduce systemic side effects.

  • Combination Therapies: Other trials are exploring Albuterol Sulfate as part of fixed-dose combinations with corticosteroids or anticholinergics to optimize bronchodilation with fewer doses (e.g., NCT03712456).

  • Safety and Pharmacokinetics: Studies continue to confirm Albuterol’s safety profile across demographics, particularly focusing on long-term effects in vulnerable groups such as children and the elderly (NCT03812389).

Regulatory and Product Development Milestones

While Albuterol Sulfate has been approved globally for decades, drug makers are pursuing new formulations and licensing agreements to increase market access. For instance, some companies are seeking approvals for preservative-free formulations to minimize adverse reactions.

Market Analysis

Historical Market Performance

The global Albuterol Sulfate market has demonstrated consistent growth driven by rising asthma and COPD prevalence. The global respiratory drug market was valued at approximately USD 22 billion in 2021, with beta-agonists accounting for a significant segment (Fortune Business Insights, 2022).

  • Key Geographies: North America leads the market, attributed to high asthma awareness and advanced healthcare infrastructure, followed by Europe and Asia. The U.S. alone accounts for over 40% of the market share in respiratory bronchodilators.

  • Product Segmentation: Albuterol Sulfate inhalers, nebulizers, and dry powder inhalers dominate sales. Metered-dose inhalers (MDIs) remain the preferred delivery format due to convenience and cost-effectiveness.

Competitive Landscape

Major pharmaceutical companies—Pfizer, Teva, Mylan (now part of Viatris), and Glenmark—hold prominent market positions. Patent expirations over the past decade have paved the way for generic versions, intensifying price competition but also expanding access.

Emerging Trends and Market Drivers

  • Generic Market Penetration: The widespread availability of generics has lowered prices, increasing prescription rates.
  • Rising Disease Prevalence: The GLOBAL burden of asthma affects an estimated 262 million people (WHO, 2020). COPD prevalence is also rising, notably in aging populations.
  • Innovations in Delivery: Development of breath-actuated inhalers and smart inhalers enhances adherence, expanding market potential.
  • Regulatory Incentives: Initiatives like FDA’s fast-track pathways for respiratory drugs influence market entry strategies.

Market Projection: 2023-2030

Forecast Overview

The Albuterol Sulfate market is projected to exhibit compounded annual growth rates (CAGR) of approximately 4-6% from 2023 through 2030, driven by continued prevalence of respiratory diseases and technological advancements in inhaler devices.

Factors Supporting Growth

  • Expanding Global Burden of Respiratory Diseases: Urbanization, pollution, and smoking contribute to increasing asthma and COPD cases, especially within developing regions.
  • Increased Adoption of Advanced Delivery Devices: The growing acceptance of smart inhalers and personalized treatment options will sustain demand.
  • Regulatory Approvals for New Formulations: Innovative formulations targeting specific populations (children, elderly) will expand market reach.
  • Strategic Collaborations and Licensing Agreements: Companies partnering for manufacturing and distribution will facilitate wider availability.

Potential Challenges

  • Market Saturation: Price competition from generics reduces profit margins.
  • Regulatory Hurdles: Delays or restrictions on new formulations can slow growth.
  • Environmental Regulations: Propellant phase-outs for inhalers utilizing ozone-depleting substances may influence formulation strategies.

Conclusions and Strategic Implications

Summary
Albuterol Sulfate remains a vital product in respiratory therapeutics, with ongoing clinical research emphasizing delivery innovations and safety enhancements. The market outlook is positive, buoyed by rising disease burden and technological innovations, yet constrained by patent expirations and regulatory dynamics.

Strategic Recommendations
Manufacturers should prioritize developing patient-centric inhaler devices—such as breath-actuated or smart inhalers—to sustain competitive advantage. Investing in formulations with improved safety profiles and targeting emerging markets can unlock additional growth. Furthermore, leveraging strategic collaborations can improve manufacturing efficiencies and market penetration.


Key Takeaways

  • Clinical Focus: Ongoing trials emphasize infants’ and elderly populations’ safety and innovative delivery systems, reflecting a shift towards personalized medicine.

  • Market Dynamics: The global market remains robust, with generics expanding access and device innovations creating differentiation opportunities.

  • Growth Drivers: Rising respiratory disease prevalence, technological advancement, and healthcare infrastructure development will underpin growth through 2030.

  • Challenges: Patent expiries, environmental regulations, and market saturation require strategic adaptation.

  • Opportunities: Formulation innovations, regional expansion, and strategic partnerships offer avenues for growth.


FAQs

1. What are the recent clinical developments for Albuterol Sulfate?
Recent trials focus on delivery system enhancements, safety in vulnerable populations, and combination therapies, aiming to improve efficacy and adherence.

2. How does the market outlook for Albuterol Sulfate look over the next decade?
The market is projected to grow at a CAGR of 4-6%, driven by rising respiratory disease burden and innovation in inhaler technology, despite challenges like patent expirations.

3. Can new formulations of Albuterol Sulfate impact its market share?
Yes. Innovative formulations—such as preservative-free or inhalers with smart capabilities—can enhance adherence and safety, supporting market expansion.

4. What are the primary competitors in the Albuterol Sulfate market?
Major players include Pfizer, Teva, Mylan (Viatris), and Glenmark, with generics dominating due to patent expirations.

5. Are there specific regions where Albuterol Sulfate demand is expected to increase significantly?
Emerging markets in Asia and Latin America are anticipated to see accelerated growth owing to increasing respiratory disease prevalence and expanding healthcare infrastructure.


References

  1. ClinicalTrials.gov. (2021). Various studies on Albuterol inhalation devices.
  2. Fortune Business Insights. (2022). Respiratory Drugs Market Size, Share & Industry Analysis.
  3. WHO. (2020). World Health Organization Global Status Report on Noncommunicable Diseases.

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