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Last Updated: January 22, 2025

CLINICAL TRIALS PROFILE FOR VOSPIRE ER


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All Clinical Trials for Vospire Er

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00550550 ↗ Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED) Completed ALK-Abelló A/S Phase 3 2007-11-01 The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.
NCT00550550 ↗ Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2007-11-01 The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.
NCT00562159 ↗ Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED) Completed ALK-Abelló A/S Phase 3 2007-11-01 This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.
NCT00562159 ↗ Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2007-11-01 This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.
NCT00649779 ↗ Fasting Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg Completed Mylan Pharmaceuticals Phase 1 2005-09-01 The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fasting conditions.
NCT00649987 ↗ Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg Completed Mylan Pharmaceuticals Phase 1 2005-09-01 The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.
NCT01851642 ↗ Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs Recruiting University of Florida 2007-09-01 The purpose of this study is to look at how Alpha-1-antitrypsin (AAT) deficiency and Cystic Fibrosis (CF) affect white blood cells in the lungs, called macrophages, and their ability to work.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vospire Er

Condition Name

Condition Name for Vospire Er
Intervention Trials
Rhinitis 2
Rhinoconjunctivitis 2
Allergy 2
Conjunctivitis 2
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Condition MeSH

Condition MeSH for Vospire Er
Intervention Trials
Rhinitis 2
Conjunctivitis 2
Paresis 1
Muscle Weakness 1
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Clinical Trial Locations for Vospire Er

Trials by Country

Trials by Country for Vospire Er
Location Trials
United States 4
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Trials by US State

Trials by US State for Vospire Er
Location Trials
North Dakota 2
New York 1
Florida 1
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Clinical Trial Progress for Vospire Er

Clinical Trial Phase

Clinical Trial Phase for Vospire Er
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Vospire Er
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Vospire Er

Sponsor Name

Sponsor Name for Vospire Er
Sponsor Trials
Merck Sharp & Dohme Corp. 2
Mylan Pharmaceuticals 2
ALK-Abelló A/S 2
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Sponsor Type

Sponsor Type for Vospire Er
Sponsor Trials
Industry 6
Other 1
U.S. Fed 1
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Clinical Trials, Market Analysis, and Projections for Vospire ER

Introduction

Vospire ER, an extended-release formulation of albuterol sulfate, is a medication used to treat bronchospasm associated with asthma and other respiratory conditions. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Adverse Events and Efficacy

Clinical trials for Vospire ER have been conducted to assess its safety and efficacy. These trials have reported various adverse events, including tremor, headache, nervousness, nausea/vomiting, tachycardia, muscle cramps, palpitations, and insomnia. The incidence of these events varied among different treatment groups, with albuterol extended-release tablets showing higher frequencies of certain adverse events compared to theophylline and placebo groups[1][4].

Pharmacological Studies

Pharmacological studies have demonstrated that albuterol, the active ingredient in Vospire ER, has a preferential effect on beta 2-adrenergic receptors. This is crucial for its therapeutic action in bronchial smooth muscle. However, it also affects the heart, where beta 2-receptors are present in smaller concentrations[1].

Market Analysis

Global Respiratory Inhalers Market

The global respiratory inhalers market, which includes medications like Vospire ER, is expected to grow significantly. The market size is projected to increase from $31.14 billion in 2022 to $43.45 billion by 2028, at a Compound Annual Growth Rate (CAGR) of 5.7% during this period. This growth is driven by the increasing prevalence of respiratory diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD), as well as technological advancements in inhaler technologies[2].

Key Drivers

  • Increasing Prevalence of Respiratory Diseases: The rising incidence of asthma, COPD, and other respiratory disorders is a major driver of the market. According to the World Health Organization, an estimated 334 million people worldwide suffer from asthma[2].
  • Technological Advancements: Innovations such as smart inhalers, which use sensors to track usage and provide feedback, are gaining popularity and contributing to market growth[2].

Market Projections

Growth in Respiratory Inhalers Segment

The segment of the market that includes medications like Vospire ER is expected to benefit from the overall growth in the respiratory inhalers market. The development of more compact and portable inhaler technologies, as well as the increasing use of combination therapies, will continue to drive demand for these products[2].

Regional Market Growth

  • North America and Europe: These regions have a significant market share due to high healthcare spending and advanced healthcare infrastructure. However, the Asia Pacific region is expected to expand at the fastest CAGR due to the increasing prevalence of infectious and chronic diseases[2][3].

Clinical Trials and R&D Expenditure

The broader clinical trials market, which includes trials for respiratory medications, is also growing. The global clinical trials market is projected to grow from $61.58 billion in 2024 to $106.78 billion by 2032, at a CAGR of 7.1%. This growth is fueled by the increasing number of clinical trials, particularly in regions outside the U.S. and EU, due to cost-effectiveness and easier regulatory processes[3].

Product Development and Approvals

The respiratory inhalers market, including Vospire ER, is expected to benefit from increasing product development activities. New medical knowledge and effective medicines, along with rising investments by major pharmaceutical companies, are leading to the development of sophisticated inhaler technologies. This includes the approval and launch of new products, which will further boost the demand for respiratory inhalers[2].

Contraindications and Warnings

While Vospire ER is effective in treating bronchospasm, it is contraindicated in patients with a history of hypersensitivity to albuterol or its components. It also comes with several warnings and precautions, including the risk of paradoxical bronchospasm, cardiovascular effects, and interactions with other medications such as MAOIs and tricyclic antidepressants[1][4].

Key Takeaways

  • Clinical Trials: Vospire ER has been tested in clinical trials, showing efficacy but also a range of adverse events.
  • Market Growth: The global respiratory inhalers market is expected to grow at a CAGR of 5.7% from 2022 to 2028.
  • Technological Advancements: Innovations in inhaler technologies are driving market growth.
  • Regional Growth: The Asia Pacific region is expected to see the fastest growth due to increasing prevalence of respiratory diseases.
  • Contraindications and Warnings: Vospire ER has specific contraindications and precautions that must be considered.

FAQs

What is Vospire ER used for?

Vospire ER is used to treat bronchospasm associated with asthma and other respiratory conditions.

What are the common adverse events associated with Vospire ER?

Common adverse events include tremor, headache, nervousness, nausea/vomiting, tachycardia, muscle cramps, palpitations, and insomnia.

How is the global respiratory inhalers market expected to grow?

The global respiratory inhalers market is expected to grow from $31.14 billion in 2022 to $43.45 billion by 2028, at a CAGR of 5.7%.

What are the key drivers of the respiratory inhalers market?

Key drivers include the increasing prevalence of respiratory diseases and technological advancements in inhaler technologies.

Are there any contraindications for Vospire ER?

Yes, Vospire ER is contraindicated in patients with a history of hypersensitivity to albuterol or its components.

Sources

  1. RxList: VoSpire ER (Albuterol Sulfate Extended-Release Tablets) - RxList
  2. The Insight Partners: Respiratory Inhalers Market Size Report, Share, Trends, Growth and Revenue Forecast to 2028
  3. Fortune Business Insights: Clinical Trials Market Size, Share, Industry Trends, Growth, 2032
  4. eMPR: VOSPIRE ER Prescription & Dosage Information - MPR - eMPR.com
  5. FDA: 208564Orig1s000 - accessdata.fda.gov

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