Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE


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All Clinical Trials for ALBUTEROL SULFATE AND 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Condition Name

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

Condition MeSH for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Intervention Trials
Lung Diseases 2
Pulmonary Disease, Chronic Obstructive 2
Lung Diseases, Obstructive 1
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Clinical Trial Locations for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Trials by Country

Trials by Country for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Location Trials
United States 14
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Trials by US State

Trials by US State for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Location Trials
Texas 2
South Carolina 1
Oregon 1
North Carolina 1
Louisiana 1
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Clinical Trial Progress for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Clinical Trial Phase

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

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

Sponsor Name

Sponsor Name for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Sponsor Trials
Dey 1
University of Texas Southwestern Medical Center 1
Boehringer Ingelheim 1
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Sponsor Type

Sponsor Type for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Sponsor Trials
Industry 2
Other 1
U.S. Fed 1
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Clinical Trials Update and Market Analysis: Albuterol Sulfate and Ipratropium Bromide (DuoNeb)

Last updated: May 3, 2026

What trials are active or recently reported for albuterol sulfate + ipratropium bromide?

Public registries track this fixed-dose combination under multiple program names and sponsor structures, typically as treatment regimens for acute bronchospasm, COPD exacerbation, and emergency department (ED) use. However, producing a complete, accurate “clinical trials update” requires current trial status, enrollment, endpoints, and publication linkage by trial identifier (NCT/EudraCT) and sponsor. That level of detail is not provided in the prompt, and no trial dataset is included to anchor updates to specific studies. Under these constraints, a complete and accurate clinical-trial update cannot be produced.

Where does this combination sit in the market?

Albuterol sulfate + ipratropium bromide is a short-acting bronchodilator (SABA + SAMA) combination used in acute settings (ED/urgent care) and outpatient settings for COPD symptom control during exacerbations. The product class competes primarily on:

  • Fast bronchodilation and symptom relief
  • Dose delivery convenience (nebules vs. inhaler formulations where available)
  • Formulary placement in respiratory therapy workflows
  • Price and contracting in institutional and payer markets

Commercial reference product

The combination is widely known by the brand name DuoNeb in the US, and it is also available as generic equivalents in many markets.

What is the market size and growth outlook?

A rigorous market analysis and projection requires market-scope definitions (geography, channel, therapeutic segment boundaries, and whether only fixed-dose combination products are counted). No market-sizing inputs, geography, time horizon, or source dataset is provided in the prompt. Under these constraints, a complete and accurate numeric market forecast cannot be produced.

What drives demand for this combination?

Demand is driven by acute and exacerbation-care settings where COPD and asthma-related bronchospasm are treated with nebulized bronchodilators:

  • Emergency department throughput and rapid symptom control needs
  • COPD exacerbation incidence and high utilization of rescue bronchodilator therapy
  • Institutional formularies that standardize ED respiratory pathways
  • Generic penetration that expands access and reduces unit pricing

What is the competitive landscape?

This combination faces competition on two axes:

1) Same-mechanism nebulized bronchodilators

  • SABA alone (albuterol) regimens
  • SAMA alone (ipratropium) regimens
  • Other fixed combinations used in acute bronchospasm protocols

2) Alternative delivery and newer bronchodilator classes

  • Maintenance COPD therapies (LAMA/LABA) may reduce reliance on nebulized rescue use in some patients, but they do not eliminate acute rescue demand.
  • In acute-care pathways, nebulized rescue remains standard when inhaler technique, severity, or clinical context supports nebulization.

Forecast logic used for planning (non-numeric)

For R&D and investment planning, demand projection for this class typically follows:

  • Baseline: COPD exacerbation and ED visit trends
  • Uptake/penetration: formulary changes, contracting, and generic availability
  • Utilization: guideline adherence in acute care and outpatient rescue patterns
  • Competitive substitution: shifts toward inhaler-based rescue, alternative bronchodilator combinations, and delivery-device preferences

Key business implications

Institutional procurement dynamics

  • Generic entry compresses price and raises volume dependence.
  • Conversion between competitor respiratory pathway regimens drives short-cycle changes in procurement.

Clinical pathway fit

  • This combination has a clear place in acute bronchospasm management because it pairs complementary bronchodilator mechanisms (beta-agonism plus muscarinic antagonism).
  • It competes less on “innovation” and more on consistency of dosing delivery and cost-effective availability.

Patent and lifecycle relevance

  • For combination products with generic competition, growth usually depends on substitution resistance in formularies and cost advantages rather than sustained premium pricing.

What actions should investors and R&D teams prioritize?

  • Commercial positioning: focus on institutional pathway alignment and dosing convenience (nebule standardization, compatibility with common nebulizers, and contracting cadence).
  • Evidence strategy: emphasize outcomes in acute-care settings where rescue bronchodilators are evaluated (symptom improvement, time-to-relief, resource utilization).
  • Portfolio strategy: treat the asset as a volume-and-access play unless a differentiated delivery form or formulation is under development.

Key Takeaways

  • Albuterol sulfate + ipratropium bromide is a well-established SABA + SAMA combination used for acute bronchospasm and COPD-related exacerbation care, with demand anchored in acute rescue utilization and institutional respiratory pathways.
  • A complete clinical trials update and quantitative market projection cannot be produced from the information provided because no trial identifiers, publication set, geography, market scope, or numeric inputs are included to ground a fact-based forecast.
  • Commercial performance for this class is driven more by formulary access, generic competition, and ED pathway adherence than by long-horizon innovation cycles.

FAQs

1) Is albuterol sulfate + ipratropium bromide used for COPD and asthma?

It is primarily used for acute bronchospasm and COPD-related exacerbation management in clinical practice pathways that support nebulized SABA + SAMA rescue therapy.

2) What differentiates this combination from albuterol alone?

It adds muscarinic antagonism (ipratropium) to beta-agonism (albuterol), aligning with protocols that target multiple bronchoconstriction mechanisms during acute episodes.

3) How does generic competition affect the market?

It typically compresses unit pricing, increases the importance of volume, and makes formulary contracting outcomes central to revenue stability.

4) Where is the highest utilization likely to occur?

Emergency department and urgent care settings, plus outpatient/clinical use during acute symptom worsening when nebulized rescue therapy is indicated.

5) What should define a market projection for this drug class?

Geography, channel mix (hospital vs retail), explicit inclusion rules (fixed-dose combination only vs broader bronchodilator substitution), and a horizon aligned to COPD exacerbation utilization patterns.


References

[1] No sources were provided in the prompt for clinical trials or market sizing/projection; no cited materials can be listed without fabricating references.

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