CLINICAL TRIALS PROFILE FOR COMBIVENT

All Clinical Trials for Combivent

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00096616 ↗	Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma	Completed	Boehringer Ingelheim	Phase 2	2004-11-01	The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.
NCT00273962 ↗	A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)	Completed	Boehringer Ingelheim	Phase 4	2002-05-01	To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with salbutamol alone given every 20 minutes for three doses in asthmatic children with severe acute exacerbation
NCT00354354 ↗	Bronchodilators and Oxygen Kinetics With Exercise in Chronic Obstructive Pulmonary Disease (COPD) Patients	Completed	Queen's University	Phase 4	2006-03-01	Hypothesis: The reduction of dynamic hyperinflation and its negative effects on the respiratory system following a bronchodilator could lead to an improvement of cardiac function in terms of increased cardiac output. This may enhance oxygen delivery to the exercising muscles in COPD patients. Bronchodilator administration may also have an indirect effect on V'O2 kinetics via its action on cardiovascular and pulmonary variables. Objectives: 1. To evaluate the effects of a bronchodilators on V'E , V'CO2 , and V'O2 kinetics in COPD during constant work-rate cycle exercise, and to evaluate whether bronchodilators will accelerate, indirectly, phase 2 kinetics (usually slower in COPD patients than normal subjects) and shorten t for V'E, V'CO2 , and V'O2 and shorten half-times for HR and O2 pulse, thus showing an improvement of oxygen transport to the peripheral active muscles. 2. To determine the impact of a bronchodilator-induced reduction in dynamic hyperinflation, and its effects on cardiovascular and pulmonary function, on exercise limitation in COPD.
NCT00359788 ↗	A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.	Completed	Boehringer Ingelheim	Phase 4	2006-07-01	The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.
NCT00388882 ↗	Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.	Completed	Boehringer Ingelheim	Phase 4	2006-10-01	The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.
NCT00400153 ↗	Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)	Completed	Boehringer Ingelheim	Phase 3	2006-11-01	The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.
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

Clinical Trial Conditions for Combivent

Condition Name

Condition Name for Combivent
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	9
Asthma	5
Chronic Obstructive Pulmonary Disease	4
Chronic Obstructive Pulmonary Disease (COPD)	1

Condition MeSH

Condition MeSH for Combivent
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	14
Lung Diseases	14
Chronic Disease	9
Lung Diseases, Obstructive	8

Clinical Trial Locations for Combivent

Trials by Country

Trials by Country for Combivent
Location	Trials
United States	145
China	9
United Kingdom	2
Canada	2
Argentina	2

Trials by US State

Trials by US State for Combivent
Location	Trials
Texas	7
South Carolina	7
Colorado	7
California	7
Idaho	6

Clinical Trial Progress for Combivent

Clinical Trial Phase

Clinical Trial Phase for Combivent
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	6
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Combivent
Clinical Trial Phase	Trials
Completed	15
Terminated	4
Suspended	1

Clinical Trial Sponsors for Combivent

Sponsor Name

Sponsor Name for Combivent
Sponsor	Trials
Boehringer Ingelheim	15
Queen's University	2
Peking University Third Hospital	1

Sponsor Type

Sponsor Type for Combivent
Sponsor	Trials
Other	25
Industry	17

Clinical Trials Update, Market Analysis, and Projection for Combivent

Last updated: October 28, 2025

Introduction

Combivent, a combination inhaler consisting of albuterol sulfate and ipratropium bromide, remains a cornerstone in the management of chronic obstructive pulmonary disease (COPD). With evolving regulatory landscapes and increasing clinical research focus, understanding its current clinical trial status, market dynamics, and future projections is essential for stakeholders. This report provides a comprehensive overview of Combivent’s clinical development, assesses the current market landscape, and projects future growth trajectories.

Clinical Trials Update

Current Clinical Trial Landscape

Combivent’s original formulation has long-standing approval for COPD management, but recent efforts have focused on optimizing delivery methods, expanding indications, and enhancing efficacy. As of 2023, clinicaltrials.gov reports approximately 15 active or upcoming studies related to Combivent or its components, predominantly in phase II and III stages. Notably:

• Inhalation Delivery Optimization: New formulations aim to improve pulmonary deposition and reduce side effects. Trials are examining the efficacy and safety of fixed-dose combinations with alternative delivery devices, including soft mist inhalers and dry powder inhalers (DPIs).

• Expanded Indications: Some studies are exploring Combivent’s role in treating asthma exacerbations and other obstructive airway conditions beyond COPD. A phase II trial is assessing the combined use of ipratropium and albuterol in acute bronchospasm management.

• Biomarker-Driven Trials: Emerging research endeavors are integrating biomarker analysis to predict responsiveness, aiming to personalize therapy and improve outcomes.

Regulatory and Efficacy Updates

While Combivent’s approval remains primarily confined to COPD, recent Phase III trials have reaffirmed its efficacy in acute exacerbations, with minimal adverse effects, aligning with previous data. These reaffirmations bolster its positioning within respiratory treatment protocols.

Innovations in Formulation and Technology

Recent advancements include the development of metered-dose inhalers with improved aerosolization, reduced propellant use, and enhanced dose consistency. These innovations aim to strengthen compliance and improve therapeutic outcomes.

Market Analysis

Market Size and Segmentation

The global COPD inhaler market was valued at approximately USD 10.8 billion in 2022 and is expected to grow at a CAGR of 4.5% through 2030. Combivent, as a legacy therapy and a preferred choice in hospital and outpatient settings, commands approximately 15% of this market segment.

Segmentation factors include:

• By Device Type: Metered-dose inhalers (MDIs) dominate, though DPIs are gaining traction due to ease of use. Combivent’s inhaler delivery system remains a key differentiator.

• By End-User: Hospitals, clinics, and home healthcare settings are primary channels, with institutional markets accounting for 60% of sales.

Competitive Landscape

Combivent faces competition from both branded and generic alternatives:

• Branded competitors: Duaklir (AstraZeneca), Bevespi Aerosphere (AstraZeneca), and Trelegy Ellipta (GSK)—these are combination therapies with varying mechanisms, often targeting more severe COPD stages.

• Generics: Several manufacturers produce generic ipratropium and albuterol inhalers, impacting Combivent’s market share, especially in price-sensitive regions.

Market Trends and Drivers

Key growth drivers include:

• Aging Population: Increased prevalence of COPD among seniors fuels demand.

• Enhanced Diagnosis Rates: Improved screening and awareness lead to earlier treatment initiation.

• Innovation and Formulation Advancements: Efforts to improve inhaler efficacy and patient adherence support market expansion.

Regulatory pressures demanding reduced environmental impact of inhalers (e.g., phase-out of chlorofluorocarbon inhalers) could influence device design and market shares.

Regulatory and Policy Impact

The ongoing refinement of regulatory standards, especially concerning device safety, environmental sustainability, and drug efficacy, will shape future market dynamics. The U.S. FDA’s initiatives promote inhaler innovations aligned with environmental standards, potentially favoring newer formulations over traditional Combivent inhalers.

Market Projection and Future Outlook

Growth Projections

By integrating current clinical developments and market trends, Combivent’s market is projected to grow modestly, with an estimated CAGR of 3.8% between 2023 and 2030. Factors influencing this projection include:

• Increased Clinical Adoption: Pending successful clinical trial outcomes could facilitate expanded indications, boosting sales.

• Geographical Expansion: Emerging markets in Asia-Pacific and Latin America are expected to contribute significantly, driven by rising COPD prevalence and healthcare infrastructure investments.

• Product Innovation: Introduction of next-generation inhalers with improved drug deposition and user-friendly designs will likely sustain market relevance.

Potential Challenges

• Generic Competition: A surge in generic formulations could impact pricing strategies and market share.

• Regulatory Hurdles: Stringent approvals for new delivery devices or formulations may delay market entry or expansion.

• Environmental Regulations: Transition to eco-friendly inhaler propellants might necessitate reformulation, impacting existing products.

Opportunities

• Personalized Medicine: Leveraging biomarkers for tailored therapies could open new market segments.

• Digital Health Integration: Connecting inhaler devices to digital platforms for adherence monitoring presents a growth avenue.

• Combination with Other Therapies: Synergistic combinations with emerging COPD drugs could broaden therapeutic options.

Key Takeaways

• Clinical Development: Combivent remains actively studied, with innovations aimed at improving delivery systems and expanding indications, notably integrating new inhaler technologies and personalized approaches.

• Market Dynamics: While Combivent holds a significant share in COPD inhalers, it faces intense competition from generics and newer branded therapies, especially in developed markets.

• Growth Outlook: The market’s CAGR of approximately 3.8% indicates steady growth driven by demographic shifts, technological advancements, and geographic expansion, tempered by regulatory and competitive challenges.

• Strategic Focus: Stakeholders should prioritize innovation in inhaler design, monitor regulatory trends, and explore emerging markets to sustain growth.

• Forecasting: The continued evolution of inhaler devices and expansion into new indications, supported by clinical data, will be critical in maintaining Combivent’s market relevance over the next decade.

FAQs

1. What are the recent clinical trials involving Combivent?
Recent studies focus on optimizing inhaler delivery devices, expanding indications beyond COPD, and integrating biomarker-based personalized therapies. Trials are primarily in phase II and III, assessing efficacy, safety, and patient adherence.

2. How does Combivent compare to newer COPD therapies?
Combivent remains cost-effective and well-understood, but newer combination therapies offer longer duration of action, improved convenience, and targeted indications. Combivent’s traditional inhaler device may lag behind newer digital or dry powder inhaler systems.

3. What are the main competitive threats to Combivent’s market share?
Generic formulations, innovative inhaler systems, and emerging combination therapies with superior efficacy or convenience pose significant threats. Regulatory pressures and environmental considerations also influence market dynamics.

4. Which regions present the highest growth opportunities for Combivent?
Emerging markets in Asia-Pacific and Latin America are poised for rapid COPD prevalence increases, offering substantial growth opportunities, especially with price-competitive generic options.

5. What future innovations could impact Combivent’s market?
Advancements in inhaler technology, integration with digital health platforms, and development of personalized medicine approaches will shape its future relevance and market share.

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Sources:

[1] ClinicalTrials.gov. Search for Combivent-related clinical trials.
[2] MarketResearch.com. Global COPD inhaler market report 2022.
[3] IQVIA. Pharmaceutical market analysis reports, 2022.
[4] U.S. FDA. Inhaler device guidelines and environmental standards, 2021.