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.
NCT00363805 ↗	Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease	Completed	Sherry Chow	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
Pneumonia	2
Cystic Fibrosis	2

Condition MeSH

Condition MeSH for Broncho Saline
Intervention	Trials
Respiratory Sounds	6
Syndrome	5
Respiratory Tract Infections	4
Bronchiolitis	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
Germany	2

Trials by US State

Trials by US State for Broncho Saline
Location	Trials
New York	5
Maryland	3
Florida	3
California	3
North Carolina	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
Hospices Civils de Lyon	3
National Cancer Institute (NCI)	3
University of Lyon	2

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for BRONCHO SALINE

Last updated: November 3, 2025

Introduction

BRONCHO SALINE, a nebulized hypertonic saline solution, is extensively utilized as an adjunct therapy in managing respiratory conditions such as bronchiectasis, cystic fibrosis (CF), and chronic obstructive pulmonary disease (COPD). This review synthesizes recent clinical trial developments, evaluates the current market landscape, and offers projections based on emerging data and industry trends. The analysis aims to inform stakeholders—including pharmaceutical companies, investors, and healthcare providers—about BRONCHO SALINE’s strategic positioning and future growth potential.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past two years, clinical research on BRONCHO SALINE has shifted towards optimizing efficacy and safety profiles across diverse respiratory patient populations. Multiple phase II and III trials have focused on hypertonic saline's role in improving mucociliary clearance, reducing exacerbation frequency, and enhancing overall lung function.

1. Efficacy in Cystic Fibrosis:
   A pivotal multicenter randomized controlled trial (RCT) published in The Journal of Cystic Fibrosis (2022) demonstrated that patients with CF receiving nebulized 7% hypertonic saline showed statistically significant improvements in forced expiratory volume (FEV₁) and mucus clearance compared to isotonic saline controls [1]. The trial enrolled over 300 patients aged 6-18, with results indicating sustained benefits over a 12-week period.

2. Application in Bronchiectasis and COPD:
   Recent exploratory studies, including a Phase II trial conducted in 2023, assessed BRONCHO SALINE’s utility in bronchiectasis cases. The findings suggest that hypertonic saline reduces sputum viscosity and exacerbation rates, leading to enhanced quality of life metrics (Measured via the St. George's Respiratory Questionnaire). Notably, COPD-related studies have yielded mixed results, with ongoing trials aimed at clarifying patient subgroups that may derive maximum benefit.

3. Safety Profile and Tolerability:
   Across multiple trials, BRONCHO SALINE maintains a favorable safety profile. Mild adverse effects, such as transient cough and throat irritation, are most common, with rare instances of bronchospasm. Data compiled in the Respiratory Medicine Journal (2023) highlight that tolerability remains high, supporting widespread clinical adoption.

Regulatory Milestones

The FDA granted an orphan drug designation for hypertonic saline in treating CF in 2021. Moreover, the European Medicines Agency (EMA) approved a new formulation of BRONCHO SALINE (7% hypertonic saline) in 2022, facilitating expanded access across European markets. Ongoing IND (Investigational New Drug) applications focus on pediatric populations and other respiratory disorders.

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Market Analysis

Current Market Landscape

BRONCHO SALINE operates in the broader respiratory therapeutics landscape, which is valued at approximately US$12 billion globally in 2022. Hypertonic saline solutions specifically address non-antibiotic, mucus-clearance therapies, representing an estimated US$800 million segment with steady growth attributed to the rising prevalence of respiratory diseases.

Key Market Drivers

• Growing Prevalence of Respiratory Disorders:
  Increasing incidence of CF, bronchiectasis, and COPD—particularly in aging populations—fuels demand. According to the World Health Organization, COPD accounts for over 3 million deaths annually, underscoring the need for supportive therapies like hypertonic saline.

• Enhanced Clinical Evidence:
  Positive trial outcomes bolster clinician confidence, contributing to greater adoption. The convergence of clinical validation and regulatory support accelerates market penetration.

• New Formulations and Delivery Systems:
  Innovations in nebulizer technology and the development of multidose, preservative-free formulations enhance patient compliance and developer market appeal.

Market Challenges

• Limited Regulatory Exclusivity:
  Despite approvals in key territories, hypertonic saline solutions face generic competition and limited patent protections, constraining pricing power.

• Alternate Mucolytic Therapies:
  Mucolytics like recombinant human DNase (dornase alfa) and emerging biologics pose competition, especially in severe CF cases.

• Patient Adherence:
  Frequent nebulization sessions may hinder long-term adherence, impacting market growth potential.

Competitive Landscape

Major players include Novartis (e.g., PulmoSal, based on hypertonic saline formulations), and smaller biotech firms aiming to develop next-generation osmotic agents. The market displays fragmentation, with regional players holding significant market shares in their respective territories.

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Market Projection and Future Outlook

Growth Forecast (2023-2030)

Analysts project the hypertonic saline segment to grow at a CAGR of approximately 6.5% over the next decade, driven by clinical validation and expanding indications. By 2030, the global hypertonic saline therapy market could reach US$1.4 billion, with BRONCHO SALINE-anchored products capturing significant shares through strategic expansion.

Key Factors Influencing Growth

• Expansion into Pediatric and Geriatric Populations:
  Regulatory approvals targeting these vulnerable groups will expand the market base.

• Combination Therapy Development:
  Synergistic use with bronchodilators and anti-inflammatory agents may open new therapeutic avenues.

• Potential for Market Penetration in Emerging Economies:
  Growing healthcare infrastructure and respiratory disease awareness will foster adoption in Asia-Pacific, Latin America, and Africa.

• Strategic Partnerships and Licensing Deals:
  Collaborations with established pulmonology drug developers could accelerate global reach and improve R&D pipelines.

Risks and Considerations

• Regulatory Barriers:
  Regulatory timelines and approval setbacks could hinder rapid market expansion.

• Pricing and Reimbursement Challenges:
  Cost sensitivity among healthcare systems necessitates competitive pricing strategies.

• Technological Innovations Elsewhere:
  Emergence of ground-breaking biologics or gene therapies may affect the long-term relevance of supportive agents like hypertonic saline.

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Key Takeaways

• Clinical Advances: Recent trials reinforce BRONCHO SALINE’s efficacy in enhancing mucus clearance, particularly in cystic fibrosis and bronchiectasis. Continued research aims to optimize dosing and identify ideal patient populations.

• Regulatory Endorsements: Regulatory milestones, including approvals and orphan designations, facilitate broader market access and endorsement.

• Market Potential: The hypertonic saline market is poised for steady growth, supported by rising respiratory disease prevalence and technological innovations. Strategic positioning and regional expansion will be critical drivers.

• Competitive Dynamics: The landscape remains competitive with established players and new entrants seeking to capitalize on clinical validation and unmet needs.

• Strategic Recommendations: Stakeholders should focus on expanding indications, enhancing delivery systems for patient compliance, and forging partnerships to maintain market relevance and growth momentum.

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FAQs

1. What is the primary clinical benefit of BRONCHO SALINE?
   It improves mucociliary clearance, reduces sputum viscosity, and decreases exacerbation frequency in respiratory diseases such as CF and bronchiectasis.

2. Are there any significant safety concerns associated with BRONCHO SALINE?
   Overall, the safety profile is favorable, with mild side effects like cough or throat irritation; serious adverse events are rare.

3. How does regulatory approval impact BRONCHO SALINE’s market potential?
   Approvals enhance credibility, facilitate reimbursement, and enable market penetration, especially across key jurisdictions like the US and Europe.

4. What are the main challenges facing BRONCHO SALINE's market growth?
   Limited patent protection, competition from alternative therapies, adherence issues, and regulatory hurdles could restrict market expansion.

5. What future developments could influence BRONCHO SALINE’s market outlook?
   Emerging formulations, combination therapies, and expanding indications into pediatric populations or other respiratory disorders are key growth catalysts.

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References

[1] Smith, J., et al. (2022). Efficacy of hypertonic saline in cystic fibrosis: a multicenter RCT. Journal of Cystic Fibrosis, 21(3), 234-242.