CLINICAL TRIALS PROFILE FOR ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

All Clinical Trials for ALBUTEROL SULFATE AND 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 AND IPRATROPIUM BROMIDE

Condition Name

Condition Name for ALBUTEROL SULFATE AND 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 AND IPRATROPIUM BROMIDE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	2
Lung Diseases	2
Asthma	1
Lung Diseases, Obstructive	1

Clinical Trial Locations for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Trials by Country

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

Trials by US State

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−

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

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

Clinical Trial Status

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

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

Sponsor Type

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

Albuterol Sulfate and Ipratropium Bromide: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Albuterol sulfate and ipratropium bromide, when combined, form a potent bronchodilator used primarily in the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory conditions. This article delves into the clinical trials, market analysis, and future projections for this drug combination.

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 bronchoconstriction[2][5].

Clinical Trials

Efficacy and Safety

Numerous clinical trials have demonstrated the efficacy and safety of the combination of albuterol sulfate and ipratropium bromide. A multicenter trial involving 534 patients with COPD showed that the combination metered-dose inhaler (MDI) aerosol was more effective than either component alone in improving pulmonary function, specifically forced expiratory volume in 1 second (FEV1)[1].

A 12-week randomized, double-blind, positive-control, crossover study involving 863 COPD patients further confirmed that the combination inhalation solution demonstrated significantly better changes in FEV1 compared to albuterol sulfate or ipratropium bromide alone. This study highlighted the rapid onset and extended duration of action of the combination therapy[5].

Comparative Studies

Studies comparing ipratropium bromide and albuterol have consistently shown that ipratropium produces a longer duration of action and greater improvement in FEV1 and forced vital capacity compared to albuterol alone. For instance, a study involving 25 subjects with moderate to severe COPD found that ipratropium produced a significantly greater improvement in FEV1 and forced vital capacity over a six-hour period[4].

Pharmacokinetics

Pharmacokinetic studies have shown that the combination of albuterol sulfate and ipratropium bromide does not significantly alter the pharmacokinetic profile of albuterol. The mean peak albuterol concentrations and area under the curve (AUC) values were similar whether administered alone or in combination with ipratropium bromide[5].

Market Analysis

Current Market Status

The combination of albuterol sulfate and ipratropium bromide is widely approved and used globally, with Boehringer Ingelheim GmbH being one of the primary manufacturers. This drug combination is a first-line treatment for COPD and is also indicated for asthma and bronchial spasm[2].

Market Demand

The demand for this combination therapy is driven by the increasing prevalence of COPD and other respiratory diseases. According to market trends, the global COPD treatment market is expected to grow significantly due to the rising number of patients and the need for effective management strategies.

Competitive Landscape

The market for COPD treatments is competitive, with several other bronchodilators available, including tiotropium bromide and combination therapies involving long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs). However, the combination of albuterol sulfate and ipratropium bromide remains a preferred option due to its proven efficacy and safety profile[3].

Market Projections

Future Growth

The market for albuterol sulfate and ipratropium bromide is projected to continue growing, driven by the increasing incidence of COPD and the aging population. Advances in inhalation technology and the development of more convenient and effective delivery systems are expected to further boost market growth.

Emerging Trends

There is a growing trend towards combination therapies that offer multiple mechanisms of action, as seen with the success of albuterol sulfate and ipratropium bromide. This trend is expected to continue, with pharmaceutical companies investing in research and development to create more effective and convenient treatment options for respiratory diseases.

Key Takeaways

• Efficacy and Safety: Clinical trials have consistently shown that the combination of albuterol sulfate and ipratropium bromide is more effective than either component alone in improving pulmonary function in patients with COPD.
• Mechanism of Action: The combination works through both β2-adrenergic and anticholinergic mechanisms to provide enhanced bronchodilation.
• Market Demand: The growing prevalence of COPD and other respiratory diseases drives the demand for this combination therapy.
• Future Growth: The market is projected to grow due to the increasing incidence of COPD and advances in inhalation technology.

FAQs

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

The primary indications include the treatment of bronchospasm associated with COPD, asthma, and bronchial spasm[2].

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

The combination works by albuterol sulfate relaxing airway smooth muscles through β2-adrenergic receptors and ipratropium bromide inhibiting muscarinic acetylcholine receptors to reduce mucus production and bronchoconstriction[2][5].

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

Clinical trials have shown that the combination is more effective than either component alone in improving FEV1 and forced vital capacity, with a rapid onset and extended duration of action[1][5].

Who are the primary manufacturers of this drug combination?

Boehringer Ingelheim GmbH is one of the well-known manufacturers of this drug combination[2].

What are the future market projections for this drug combination?

The market is projected to grow due to the increasing incidence of COPD, advances in inhalation technology, and the preference for combination therapies with multiple mechanisms of action.

Sources

1. JAMA Internal Medicine: "For COPD a Combination of Ipratropium Bromide and Albuterol Sulfate Is More Effective at Improving Pulmonary Function Than Albuterol Base Alone."
2. Synapse by Patsnap: "Ipratropium bromide/Albuterol sulfate's R&D Progress."
3. ClinicalTrials.gov: "CLINICAL STUDY PROTOCOL Protocol No. TB-DPI-301."
4. JAMA Internal Medicine: "A Comparison of the Effect of Ipratropium and Albuterol in the Treatment of Chronic Obstructive Airway Disease."
5. Drugs.com: "Ipratropium and Albuterol: Package Insert / Prescribing Info."