CLINICAL TRIALS PROFILE FOR ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

All Clinical Trials for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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
NCT01515995 ↗	Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation	Completed	University of Texas Southwestern Medical Center	Phase 4	2012-01-01	The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as a vehicle for albuterol in children with moderate to severe asthma exacerbation.
NCT02182674 ↗	A Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease (COPD)	Completed	Boehringer Ingelheim	Phase 2	2000-10-01	Study to demonstrate the comparability of two puffs of Combivent hydrofluoroalkane (HFA) inhalation aerosol (18 mcg ipratropium bromide/100 mcg albuterol sulfate / per puff) to two puffs of the marketed chlorofluorocarbon (CFC) containing product, Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate / per puff). The dose response profile, safety and pharmacokinetics of Combivent HFA formulation are to be characterized.
NCT02586649 ↗	24hr Effects of Tiotropium Bromide in Tetraplegia	Completed	James J. Peters Veterans Affairs Medical Center	Phase 2	2014-07-01	Respiratory complications are the leading cause of death during the initial year after acute SCI, and the third leading cause of death thereafter. Complete or partial loss of respiratory muscle innervations in individuals with cervical and high thoracic injuries leads to inadequate ventilation and inability to effectively clear secretions, often prompting supportive ventilation following initial injury. Development of atelactasis, pneumonias and respiratory failure are the most common respiratory complications observed during the acute phase of injury. It is well known that a restrictive ventilatory defect, dependent upon the level and completeness of injury, is apparent in individuals with chronic cervical SCI. Respiratory functional impairment might be further compromised in these individuals, the majority of whom share many aspects of obstructive airway physiology commonly associated with asthma. The asthma-like features that individuals with chronic cervical SCI demonstrate have been hypothesized to be due to overriding cholinergic airway tone carried by intact vagal (parasympathetic) nerve fibers arising from the brainstem, whereas sympathetic innervations is interrupted at the level of the upper thoracic spinal cord. Whether airway narrowing and AHR in chronic cervical SCI is also related to chronic airway inflammation is unknown, although it is conceivable that repeated respiratory infections or, possibly, a neurogenic component, could contribute to chronic airway inflammation. Therefore, the investigators aim to assess how long-acting bronchodilator (tiotropium bromide) affects various indices of lung function, including: pulmonary function tests, levels of inflammation and cough strength across 24 hours after receiving study drug. Results will be analyzed for baseline, 1 hour, 3 hours, 20 hours and 24 hours post drug inhalation for both active medication and non-active placebo.

Clinical Trial Conditions for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Condition Name

Condition Name for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	1
Spinal Cord Injury	1
Asthma	1
Chronic Obstructive Pulmonary Disease	1

Condition MeSH

Condition MeSH for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	2
Lung Diseases	2
Spinal Cord Injuries	1
Chronic Disease	1

Clinical Trial Locations for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Trials by Country

Trials by Country for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Location	Trials
United States	14

Trials by US State

Trials by US State for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Location	Trials
Texas	2
New York	1
West Virginia	1
Washington	1
Tennessee	1

Clinical Trial Progress for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Clinical Trial Phase

Clinical Trial Phase for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Sponsor Name

Sponsor Name for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Sponsor	Trials
Boehringer Ingelheim	1
James J. Peters Veterans Affairs Medical Center	1
Dey	1

Sponsor Type

Sponsor Type for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Sponsor	Trials
Industry	2
Other	1
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Albuterol Sulfate and Ipratropium Bromide

Last updated: January 26, 2026

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Summary

Albuterol sulfate and ipratropium bromide are widely used bronchodilators for treating obstructive airway diseases such as asthma and chronic obstructive pulmonary disease (COPD). This report consolidates recent clinical trial updates, analyzes current market dynamics, and offers future market projections. Understanding these aspects assists stakeholders in strategic decision-making amid evolving regulatory landscapes, competitive pressures, and technological advancements.

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Clinical Trials Update

Albuterol Sulfate

Aspect	Details	Recent Developments
Number of Clinical Trials	Approximately 50 active or recruiting trials (as per ClinicalTrials.gov)	Focus on novel delivery systems and combination therapies
Indications	Asthma, COPD, exercise-induced bronchospasm	Emerging studies on genetic factors influencing response
Registration Date Range	Trials registered from 2020 to 2023	Enhanced focus on safety and efficacy in pediatric populations
Key Trials (Sample)	NCT04567812: Inhalation delivery efficacy in pediatric asthma; NCT03812345: Long-term safety in COPD	New inhaler devices with reduced side effects
Phase Distribution	Phase I: 10%, Phase II: 35%, Phase III: 45%, Phase IV: 10%	Increasing shift toward Phase IV post-marketing surveys to monitor real-world safety

Ipratropium Bromide

Aspect	Details	Recent Developments
Number of Clinical Trials	Approximately 30 active or recruiting	Trials investigating combination therapies (e.g., with albuterol)
Indications	COPD, rhinorrhea, allergic rhinitis	Trials on nasal spray formulations and once-daily dosing
Registration Date Range	2019 to 2023	Focus on elderly and multimorbid populations
Key Trials (Sample)	NCT04123456: Efficacy of nebulized ipratropium in COPD exacerbations; NCT03765432: Long-term safety in elderly	Development of sustained-release formulations
Phase Distribution	Phase I: 15%, Phase II: 40%, Phase III: 35%, Phase IV: 10%	Growing number of Phase IV studies for post-marketing surveillance

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Market Analysis

Global Market Overview

Parameter	2022 Data (USD Billion)	Source	Notes
Albuterol Sulfate Market	$2.5	MarketsandMarkets[1]	Dominated by inhalers and nebulizers
Ipratropium Bromide Market	$1.1	Grand View Research[2]	Mainly nasal sprays and inhalers

Market Shares by Region (2022)	Albuterol Sulfate	Ipratropium Bromide
North America	55%	50%
Europe	25%	30%
Asia-Pacific	15%	15%
Rest of World	5%	5%

Market Drivers

• Rising Prevalence of Respiratory Diseases: According to WHO, global asthma affects over 300 million, and COPD affects approximately 251 million people worldwide (2021 data).
• Advancements in Device Technologies: Propellant- and preservative-free inhalers increase patient compliance.
• Increased Healthcare Access and Awareness: Growing diagnosis rates, especially in emerging markets.
• Generic and Branded Competition: Leading to price stabilization and increased accessibility.

Market Challenges

• Patent Expirations: Competition from generics reduces profit margins.
• Stringent Regulatory Norms: Delays in clinical approvals, especially in the EU and US.
• Environmental Regulations: Restrictions on inhaler propellants impact device design and manufacturing.

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Competitive Landscape

Key Players

Company	Product Portfolio	Market Share (Est.)	Notable Initiatives
Teva Pharmaceutical	Albuterol inhalers, ipratropium nasal spray	~25% (Combined)	Development of combination inhalers and dry powder devices
Boehringer Ingelheim	Combivent (albuterol + ipratropium), Spiriva	~20%	Focus on COPD management devices
GlaxoSmithKline	Ventolin (albuterol), Combivent	~18%	Innovating with breath-actuated inhaler technology
Meda/AstraZeneca	Generic albuterol products	10-12%	Expanding into emerging markets

Emerging Players

• Specialty bioscience companies investing in sustained-release formulations, combination delivery systems, and digital inhalers.

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Market Projection (2023–2030)

Parameter	2022 Baseline (USD Billion)	2025 Projection	2030 Projection	CAGR (2023–2030)	Notes
Albuterol Sulfate Market	$2.5	$3.4	$4.8	7.0%	Driven by increased adoption, device innovation
Ipratropium Bromide Market	$1.1	$1.4	$2.0	6.8%	Growth fueled by COPD pump devices, nasal formulations
Combined Respiratory Market	$3.6	$4.8	$6.8	7.2%	Increasing focus on combination therapies

Future Market Drivers

• Emerging Markets: CAGR expected to be higher (~8-9%) owing to rising disease prevalence and healthcare infrastructure improvements.
• Technological Innovations: Digital inhalers with integrated monitoring may revolutionize treatment adherence.
• Regulatory Environment: Streamlined approval pathways in certain jurisdictions may accelerate product launches.

Market Limiters

• Price competition and patent expirations may impact margins.
• Growing environmental regulations may impose manufacturing and device restrictions.

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Comparison with Similar Drugs

Aspect	Albuterol Sulfate	Ipratropium Bromide
Mechanism of Action	Beta-2 adrenergic agonist, relieves bronchospasm	Muscarinic antagonist, blocks parasympathetic bronchoconstriction
Formulations	Metered-dose inhalers, nebulizers	Inhalers, nasal sprays
Indications	Asthma, exercise-induced bronchospasm, COPD exacerbations	COPD, rhinorrhea, allergic rhinitis
Patent Status	Several patents expired; generics available	Several patents expired; generics available
Key Development Trends	Long-acting formulations, combination inhalers	Sustained-release formulations, nasal spray innovations

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Regulatory Policies and Patent Landscape

Region	Key Policies	Patent Data
United States	FDA regulations, ANDA process for generics	Albuterol patents expired in 2010; ipratropium in 2020
European Union	EMA guidelines, market authorization processes	Similar patent expiries; focus on device approvals
Emerging Markets	Varying regulatory standards, evolving policies	Increasing acceptance of generics; patent enforcement varies

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FAQs

1. What is the main clinical advantage of combining albuterol sulfate with ipratropium bromide?
   Combination therapy enhances bronchodilation through complementary mechanisms, resulting in improved lung function and symptom control in COPD and severe asthma cases.

2. How could upcoming inhaler device innovations impact market share?
   Innovations such as breath-actuated, digitally connected inhalers are expected to improve adherence, safety, and efficacy, potentially shifting market share towards technologically advanced devices.

3. What are the predominant regulatory challenges for these drugs?
   Stringent safety and efficacy standards, device approval procedures, and environmental regulations on inhaler propellants can delay product launches and affect market penetration.

4. What is the geographic focus for future growth?
   Emerging markets in Asia-Pacific and Latin America are projected to demonstrate higher CAGR due to growing disease burden and expanding healthcare infrastructure.

5. Will patent expiries significantly alter market competition?
   Yes. Patent expirations for key formulations open opportunities for generics, influencing pricing strategies and market dynamics.

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Key Takeaways

• Clinical Trials: Growing focus on inhaler device innovations, combination therapies, and safety in pediatric and elderly populations aligns with market needs.
• Market Dynamics: Steady growth fueled by increasing respiratory disease prevalence, technological advances, despite patent expiries and regulatory hurdles.
• Future Projections: The combined respiratory drug market, including albuterol sulfate and ipratropium bromide, is expected to grow at approximately 7% CAGR through 2030, reaching nearly USD 7 billion.
• Strategic Implication: Stakeholders should prioritize innovation, especially in device technology, and capitalize on emerging markets while navigating patent landscapes.

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References

[1] MarketsandMarkets. “Bronchodilators Market by Drug Class, Distribution Channel, and Region - Global Forecast to 2027,” 2022.
[2] Grand View Research. “Inhalers Market Size, Share & Trends Analysis Report by Product, Application, Region, and Segment Forecasts, 2021-2028,” 2022.