CLINICAL TRIALS PROFILE FOR BRONCHO SALINE

All Clinical Trials for Broncho Saline

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00029328 ↗	Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation	Completed	FDA Office of Orphan Products Development	Phase 1/Phase 2	2001-09-01	The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.
NCT00041561 ↗	Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics	Terminated	Mallinckrodt	Phase 3	2002-01-01	The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.
NCT00127985 ↗	6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome	Unknown status	Pfizer	Phase 4	2005-08-01	Background: Systemic corticosteroids are considered in patients with an adverse clinical course suffering from conditions like the acute respiratory distress syndrome (ARDS) and septic shock. Treated patients not only show improved respiratory function, but also hemodynamic status and overall multiple organ dysfunction score. Objective: To evaluate the safety and effectiveness of 6-methyl-prednisolone on the clinical course of multiple organ dysfunction syndrome (MODS). Design: Multi-center, double-blind, randomized, placebo-controlled. Intervention: Intravenous administration of 6-methyl-prednisolone or placebo (aqueous solution). The duration of the study medication administration protocol is 32 days (1). Primary Endpoints: 1. All cause Intensive Care Unit (ICU) and 28-day mortality 2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.
NCT00127985 ↗	6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome	Unknown status	Hospital Universitario Principe de Asturias	Phase 4	2005-08-01	Background: Systemic corticosteroids are considered in patients with an adverse clinical course suffering from conditions like the acute respiratory distress syndrome (ARDS) and septic shock. Treated patients not only show improved respiratory function, but also hemodynamic status and overall multiple organ dysfunction score. Objective: To evaluate the safety and effectiveness of 6-methyl-prednisolone on the clinical course of multiple organ dysfunction syndrome (MODS). Design: Multi-center, double-blind, randomized, placebo-controlled. Intervention: Intravenous administration of 6-methyl-prednisolone or placebo (aqueous solution). The duration of the study medication administration protocol is 32 days (1). Primary Endpoints: 1. All cause Intensive Care Unit (ICU) and 28-day mortality 2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.
NCT00363805 ↗	Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease	Completed	National Cancer Institute (NCI)	Phase 2	2004-05-01	RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea or polyphenon E may prevent cancer from forming in former smokers with chronic obstructive pulmonary disease. PURPOSE: This randomized phase II trial is studying how well green tea or polyphenon E work in preventing lung cancer in former smokers with chronic obstructive pulmonary disease.

Clinical Trial Conditions for Broncho Saline

Condition Name

Condition Name for Broncho Saline
Intervention	Trials
Wheezing	4
Asthma	3
Cystic Fibrosis	2
Respiratory Insufficiency	2

Condition MeSH

Condition MeSH for Broncho Saline
Intervention	Trials
Respiratory Sounds	6
Syndrome	5
Respiratory Tract Infections	4
Communicable Diseases	3

Clinical Trial Locations for Broncho Saline

Trials by Country

Trials by Country for Broncho Saline
Location	Trials
United States	44
France	7
Poland	5
United Kingdom	3
Switzerland	2

Trials by US State

Trials by US State for Broncho Saline
Location	Trials
New York	5
North Carolina	3
Maryland	3
Florida	3
California	3

Clinical Trial Progress for Broncho Saline

Clinical Trial Phase

Clinical Trial Phase for Broncho Saline
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	8
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Broncho Saline
Clinical Trial Phase	Trials
Completed	15
Recruiting	9
Unknown status	6

Clinical Trial Sponsors for Broncho Saline

Sponsor Name

Sponsor Name for Broncho Saline
Sponsor	Trials
National Cancer Institute (NCI)	3
Hospices Civils de Lyon	3
University of Lyon	2

Sponsor Type

Sponsor Type for Broncho Saline
Sponsor	Trials
Other	52
Industry	16
NIH	4

Broncho Saline: Clinical Trials, Market Analysis, and Projections

Introduction

Broncho Saline, often referred to as hypertonic saline, is a medical solution used in various respiratory conditions, including bronchiolitis, bronchiectasis, and other respiratory diseases. This article will delve into the clinical trials, market analysis, and projections for Broncho Saline, providing a comprehensive overview of its efficacy, market trends, and future outlook.

Clinical Trials: Efficacy of Hypertonic Saline

Bronchiolitis Studies

Several clinical trials have investigated the efficacy of hypertonic saline in treating bronchiolitis, a common respiratory illness in infants and young children.

• A multicentre, double-blind, randomised controlled trial compared the effects of nebulised 3% and 6% hypertonic saline with 0.9% normal saline in children hospitalised with viral bronchiolitis. The study found that neither 3% nor 6% hypertonic saline reduced the duration of hospital stay, the need for supplemental oxygen, or tube feeding compared to normal saline[1].
• Another study conducted in the emergency department setting found that nebulised 3% hypertonic saline decreased hospital admission rates for children with bronchiolitis but did not significantly reduce the length of stay or respiratory distress scores compared to normal saline[3].

Other Respiratory Conditions

• In non-cystic fibrosis bronchiectasis, current guidelines recommend the use of hypertonic saline solutions. These solutions help in loosening and clearing mucus, improving lung function and quality of life for patients[5].

Market Analysis

Global Market Size and Growth

The global market for normal saline, which includes hypertonic saline solutions, is substantial and growing.

• The global normal saline for parenteral use market was valued at USD 3.44 billion in 2023 and is projected to grow to USD 5.48 billion by 2030, at a Compound Annual Growth Rate (CAGR) of 6.9% during the forecast period[2].

Key Drivers of Market Growth

• Increasing Prevalence of Respiratory Diseases: The rising incidence of respiratory conditions such as bronchiolitis, bronchiectasis, and other diseases drives the demand for hypertonic saline solutions.
• Hospital Admissions and Surgical Procedures: The growing number of hospital admissions and surgical procedures, particularly in regions with improving healthcare infrastructure, contributes to the market growth[2].
• Dehydration and Sepsis: The increasing cases of dehydration and sepsis, especially in neonates, further boost the demand for normal and hypertonic saline solutions[2].

Market Segmentation

• By Type: The market is segmented into glass bottles and plastic bottles, with the plastic bottles segment expected to dominate due to their safety and convenience[2].
• By Application: The intravenous segment accounts for the major portion of the market share, driven by the high incidence of vomiting, diarrhea, and food poisoning[2].

Regional Analysis

• North America: This region holds a significant share of the market, driven by the strategic presence of key players and the rising uptake of saline solutions. The North American market was valued at USD 1.26 billion in 2022[2].
• Latin America and Middle East & Africa: These regions are expected to grow due to improving healthcare infrastructure and a high prevalence of dehydration[2].

Market Projections

Future Growth

• The market is projected to continue growing at a CAGR of 6.9% from 2023 to 2030, driven by the increasing demand for saline solutions in various medical specialties[2].

Key Players

• Companies like Baxter and Kelun Group are leading the market due to their strong distribution networks and high manufacturing capacities. Strategic collaborations and agreements, such as the distribution agreement between Grifols S.A. and Henry Schein Inc., also contribute to market growth[2].

Challenges and Opportunities

Challenges

• Supply Chain Issues: Historical shortages, such as those faced by hospitals in the U.S. after Hurricane Maria, highlight the need for robust supply chain management to meet the growing demand[2].
• Shift to Balanced Fluids: The gradual shift towards balanced fluids could potentially hamper the market growth of normal saline solutions[2].

Opportunities

• Improving Healthcare Infrastructure: The improvement in healthcare infrastructure in regions like Latin America and the Middle East & Africa presents opportunities for market expansion[2].
• Technological Advancements: Innovations in packaging, such as the preference for plastic bottles over glass, can enhance market growth by addressing safety and convenience concerns[2].

Key Takeaways

• Efficacy in Bronchiolitis: Clinical trials show mixed results, with some indicating a reduction in hospital admission rates but not in length of stay or respiratory distress scores.
• Market Growth: The global market for normal saline, including hypertonic saline, is projected to grow significantly, driven by increasing respiratory diseases and hospital admissions.
• Regional Dominance: North America leads the market, with Latin America and the Middle East & Africa showing potential for growth.
• Key Players: Companies like Baxter and Kelun Group dominate the market due to their strong distribution networks and manufacturing capacities.

FAQs

What is the primary use of hypertonic saline in respiratory conditions?

Hypertonic saline is primarily used to loosen and clear mucus, reduce airway obstruction, and improve respiratory function in conditions such as bronchiolitis and bronchiectasis.

How does hypertonic saline compare to normal saline in treating bronchiolitis?

Clinical trials suggest that hypertonic saline may reduce hospital admission rates for bronchiolitis but does not significantly reduce the length of hospital stay or respiratory distress scores compared to normal saline.

What drives the growth of the normal saline market?

The growth is driven by the increasing prevalence of respiratory diseases, hospital admissions, surgical procedures, and cases of dehydration and sepsis.

Which region dominates the normal saline market?

North America currently dominates the market, driven by the strategic presence of key players and the rising uptake of saline solutions.

What are the challenges facing the normal saline market?

Challenges include supply chain issues, historical shortages, and the gradual shift towards balanced fluids, which could hamper market growth.

Sources

1. European Respiratory Journal: "The effect of 3% and 6% hypertonic saline in viral bronchiolitis"[1]
2. Fortune Business Insights: "Normal Saline for Parenteral Use Market Growth Report [2030]"[2]
3. PubMed: "Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial"[3]
4. NIHR: "The MARCH Trial - Mucoactives in Acute Respiratory failure"[4]
5. SAGE Journals: "Nebulized hypertonic saline in noncystic fibrosis bronchiectasis"[5]

Last updated: 2025-01-02