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
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.
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.
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
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.

Clinical Trial Conditions for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Trials by Country

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

Trials by US State

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−

Trials by US State for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Location	Trials
Texas	2
South Carolina	1
Oregon	1
North Carolina	1
Louisiana	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
Dey	1
University of Texas Southwestern Medical Center	1
Boehringer Ingelheim	1

Sponsor Type

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

Albuterol Sulfate and Ipratropium Bromide: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Albuterol sulfate and ipratropium bromide are two potent bronchodilators commonly used in the treatment of respiratory diseases such as asthma, bronchial spasm, and chronic obstructive pulmonary disease (COPD). This article provides an in-depth look at the clinical trials, market analysis, and future projections for this combination therapy.

Mechanism of Action

The combination of albuterol sulfate and ipratropium bromide works through two distinct mechanisms to provide enhanced bronchodilation. Albuterol sulfate, a β2-adrenergic agonist, relaxes the smooth muscles in the airways, leading to bronchodilation and improved airflow. Ipratropium bromide, an anticholinergic agent, inhibits muscarinic acetylcholine receptors, reducing mucus production and decreasing bronchoconstriction[2][5].

Clinical Trials

Efficacy in Acute Asthma

A randomized, double-blind, controlled clinical trial compared the efficacy of continuous nebulized albuterol alone versus albuterol combined with ipratropium bromide in adult patients with acute asthma. The study found no statistically significant differences in the improvement of peak expiratory flow rates (PEFR) at 60 and 120 minutes between the two treatment groups. However, the combination therapy did not show a significant advantage over albuterol alone in terms of admission rates[1].

Efficacy in COPD

A multinational, randomized, double-blind study evaluated the efficacy and safety of ipratropium bromide/albuterol delivered via a Respimat inhaler compared to a chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and ipratropium Respimat inhaler in patients with COPD. The study demonstrated that the ipratropium bromide/albuterol Respimat inhaler had comparable bronchodilator efficacy to the MDI and superior efficacy to ipratropium alone. All active treatments were well tolerated[4].

Pharmacokinetics and Pulmonary Function

A double-blind, double-period, crossover study assessed the pharmacokinetics and pulmonary function of ipratropium bromide and albuterol sulfate inhalation solution. The study showed that each component contributed to the improvement in pulmonary function, particularly during the first 4 to 5 hours after dosing. The combination solution was significantly more effective than albuterol sulfate or ipratropium bromide alone[5].

Market Analysis

Current Market Status

The combination of ipratropium bromide and albuterol sulfate is widely approved and used globally, with approvals in multiple countries since its initial approval in France in January 1995. It is manufactured by Boehringer Ingelheim GmbH, a prominent pharmaceutical company[2].

Market Demand

The demand for this combination therapy is driven by the high prevalence of COPD and asthma. According to the World Health Organization (WHO), COPD affects over 64 million people worldwide, and asthma affects approximately 340 million people. The need for effective bronchodilators that can manage symptoms and improve quality of life for these patients continues to grow[2].

Competitive Landscape

The market for COPD and asthma treatments is highly competitive, with various inhalation devices and formulations available. However, the combination of ipratropium bromide and albuterol sulfate remains a preferred option due to its dual mechanism of action and proven efficacy. The introduction of new inhaler technologies, such as the Respimat inhaler, has also enhanced patient compliance and treatment outcomes[4].

Projections and Future Outlook

Growing Prevalence of Respiratory Diseases

The increasing prevalence of COPD and asthma, coupled with an aging population and rising air pollution, is expected to drive the demand for effective bronchodilators. This trend is likely to continue, making the combination of ipratropium bromide and albuterol sulfate a vital component in respiratory disease management.

Advancements in Inhaler Technology

Advancements in inhaler technology, such as the development of more user-friendly and efficient devices, are expected to improve patient adherence and treatment outcomes. The Respimat inhaler, for example, has shown comparable efficacy to traditional MDIs while offering a more convenient and environmentally friendly option[4].

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of pharmaceutical products. As regulatory bodies continue to emphasize the importance of dual-therapy approaches for managing complex respiratory conditions, the combination of ipratropium bromide and albuterol sulfate is likely to remain a favored treatment option.

Key Takeaways

• Dual Mechanism of Action: The combination of albuterol sulfate and ipratropium bromide provides enhanced bronchodilation through both β2-adrenergic and anticholinergic mechanisms.
• Clinical Efficacy: Clinical trials have demonstrated the efficacy of this combination in managing COPD and acute asthma, although some studies show no significant advantage over albuterol alone in certain contexts.
• Market Demand: The high prevalence of COPD and asthma drives the demand for this combination therapy.
• Future Outlook: Growing prevalence of respiratory diseases and advancements in inhaler technology are expected to sustain the market for this combination.

FAQs

What are the primary indications for the use of ipratropium bromide and albuterol sulfate?

The primary indications include the treatment of bronchospasm associated with COPD and acute asthma.

How does the combination of ipratropium bromide and albuterol sulfate work?

The combination works by targeting both β2-adrenergic receptors (albuterol sulfate) to relax airway muscles and muscarinic acetylcholine receptors (ipratropium bromide) to reduce mucus production and bronchoconstriction.

What are the key findings from clinical trials on this combination therapy?

Clinical trials have shown that the combination has comparable or superior efficacy to monotherapy in managing COPD and acute asthma, with no significant differences in some contexts.

Which companies are involved in the manufacture and distribution of this combination therapy?

Boehringer Ingelheim GmbH is a prominent manufacturer of this combination therapy.

What are the potential future trends in the market for this combination therapy?

The market is expected to grow due to increasing prevalence of respiratory diseases, advancements in inhaler technology, and favorable regulatory environments.

Sources

1. PubMed: A randomized, clinical trial comparing the efficacy of continuous nebulized albuterol alone vs. albuterol and ipratropium bromide in adult Emergency Department (ED) patients with acute asthma[1].
2. Synapse: Ipratropium bromide/Albuterol sulfate's R&D Progress[2].
3. ClinicalTrials.gov: CLINICAL STUDY PROTOCOL Protocol No. TB-DPI-301[3].
4. PubMed: Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler[4].
5. Drugs.com: Ipratropium Bromide and Albuterol Sulfate Inhalation Solution[5].