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Last Updated: April 27, 2025

CLINICAL TRIALS PROFILE FOR SURVANTA


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All Clinical Trials for Survanta

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005774 ↗ Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants Terminated National Center for Research Resources (NCRR) Phase 3 2000-05-01 Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
NCT00005774 ↗ Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants Terminated NICHD Neonatal Research Network Phase 3 2000-05-01 Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
NCT00146497 ↗ Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants Terminated China Medical University Hospital Phase 4 2004-08-01 Pulmonary inflammation plays an important role in the development of chronic lung disease (CLD) in preterm infants. This inflammation occurs very early in postnatal life. Any therapy that could be beneficial in preventing CLD should be started very early. The investigators' previous double-blind study has shown that early (< 12 hours) postnatal use of intravenous dexamethasone for 4 weeks significantly suppressed pulmonary inflammation and significantly reduced the incidence of CLD. However, the use of dexamethasone was associated with increased incidence of infection and sepsis. Their follow-up study also suggested an increase in the incidence of psychomotor anomalies. As compared to intravenous administration, endotracheal instillation will provide more local anti-inflammatory effects and less systemic side effects. Infants will be eligible for the study if their birth weight (BW) is < 1500 gm and if they had severe respiratory distress syndrome (RDS) requiring mechanical ventilation shortly after birth. After informed consent is obtained, the infant will be randomly assigned depending on the condition of the infant. The primary outcome is the change in cytokines (interleukin-6, 8, 10 and TNF-α) levels in BAL fluid. Chronic lung disease (CLD) was judged at 36 postmenstrual weeks. Infants in the study group (S/B group) received surfactant (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose) and Budesonide (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose), while those in the control group (S group) received surfactant (Survanta® Abbott, 100 mg/kg/dose) and saline (1mL/kg).
NCT00767039 ↗ Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Dey LP Phase 4 2005-01-01 Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT00767039 ↗ Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Alan Fujii Phase 4 2005-01-01 Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT00883532 ↗ Prevention of Chronic Lung Disease (CLD) in Preterm Infants Unknown status Cathay General Hospital Phase 4 2009-04-01 Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs. The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.
NCT00883532 ↗ Prevention of Chronic Lung Disease (CLD) in Preterm Infants Unknown status Chang Gung Memorial Hospital Phase 4 2009-04-01 Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs. The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Survanta

Condition Name

Condition Name for Survanta
Intervention Trials
Respiratory Distress Syndrome 7
Infant, Newborn 2
Respiratory Insufficiency 1
Infant, Low Birth Weight 1
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Condition MeSH

Condition MeSH for Survanta
Intervention Trials
Respiratory Distress Syndrome, Newborn 9
Respiratory Distress Syndrome, Adult 9
Respiratory Distress Syndrome 9
Syndrome 4
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Clinical Trial Locations for Survanta

Trials by Country

Trials by Country for Survanta
Location Trials
United States 27
Taiwan 2
Turkey 1
China 1
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Trials by US State

Trials by US State for Survanta
Location Trials
Michigan 4
Texas 2
Tennessee 2
Ohio 2
New Mexico 2
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Clinical Trial Progress for Survanta

Clinical Trial Phase

Clinical Trial Phase for Survanta
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Survanta
Clinical Trial Phase Trials
Unknown status 3
Completed 3
Terminated 3
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Clinical Trial Sponsors for Survanta

Sponsor Name

Sponsor Name for Survanta
Sponsor Trials
NICHD Neonatal Research Network 2
China Medical University Hospital 2
All India Institute of Medical Sciences, New Delhi 1
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Sponsor Type

Sponsor Type for Survanta
Sponsor Trials
Other 31
Industry 2
NIH 1
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SURVANTA: Clinical Trials, Market Analysis, and Projections

Introduction to SURVANTA

SURVANTA (beractant) is an intratracheal suspension used to treat Respiratory Distress Syndrome (RDS) in premature infants. It is a bovine lung extract surfactant that helps to reduce the surface tension in the lungs, improving lung compliance and oxygenation.

Clinical Trials and Efficacy

Historical Clinical Trials

SURVANTA has been extensively studied in various clinical trials. These include six single-dose and four multiple-dose randomized, multi-center, controlled clinical trials involving approximately 1700 infants. Additionally, three open trials, including a Treatment IND, involved more than 8500 infants[1].

  • Prevention and Rescue Studies: In these trials, SURVANTA significantly reduced the incidence of RDS, mortality due to RDS, and air leak complications. Infants receiving SURVANTA within 15 minutes of birth showed improved lung pressure-volume measurements, lung compliance, and oxygenation[1].

  • Follow-Up Evaluations: Long-term follow-up evaluations at six and twelve months showed no clinically important differences in pulmonary and neurologic sequelae between treated and control groups. However, SURVANTA-treated infants had less cerebral palsy and a reduced need for supplemental oxygen[1].

Ongoing and Terminated Trials

  • Aerosolized SURVANTA: A Phase I/II clinical trial investigating the use of aerosolized SURVANTA in neonatal RDS was terminated. This trial aimed to explore a non-invasive method of delivering surfactant, but it is no longer recruiting participants[4].

Market Analysis

Market Growth and Drivers

The respiratory distress syndrome market, which includes SURVANTA, is expected to grow at a CAGR of 4.56% from 2024 to 2034. This growth is driven by advancements in surfactant therapies, non-invasive ventilation techniques, and the use of precision medicine[2].

  • Surfactant Therapies: Innovations in both natural and synthetic surfactants are key drivers. Companies like Chiesi Farmaceutici and Windtree Therapeutics are at the forefront of developing and improving surfactant therapies. Chiesi's Curosurf® and Windtree's Aerosurf® are notable examples of products aimed at enhancing lung function and reducing inflammation in neonates[2].

Competitive Landscape

  • Key Players: The market includes prominent players such as Chiesi Farmaceutici and Windtree Therapeutics. These companies are continuously innovating and expanding their product lines to address the needs of neonatal care[2].

  • Regional Market: The market is analyzed across several countries, including the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. Each region's historical, current, and future epidemiology scenario, market performance, and therapeutic categories are scrutinized[2].

Market Projections

Future Outlook

The respiratory distress syndrome market is poised for significant growth, driven by technological advancements and increased prevalence of the condition.

  • Innovative Therapies: The introduction of novel surfactant therapies that more effectively mimic natural surfactants is expected to reduce the incidence and severity of RDS in preterm infants. This includes both natural surfactants like Curosurf® and synthetic formulations like Aerosurf®[2].

  • Non-Invasive Techniques: The development of non-invasive methods for surfactant delivery, such as aerosolized surfactants, aims to minimize the trauma and complications associated with intubation. Although the aerosolized SURVANTA trial was terminated, the concept remains promising and could see future iterations[2][4].

Economic and Clinical Efficiency

Studies comparing different surfactants have shown that SURVANTA is particularly effective for infants with less than 32 weeks' gestation. This specificity in clinical conditions highlights the need for policymakers and healthcare providers to prioritize the use of the most effective surfactants based on gestational age and clinical needs[5].

Key Takeaways

  • Clinical Efficacy: SURVANTA has been proven to significantly reduce the incidence of RDS, mortality, and air leak complications in premature infants.
  • Market Growth: The RDS market is expected to grow at a CAGR of 4.56% from 2024 to 2034, driven by innovations in surfactant therapies.
  • Competitive Landscape: Key players like Chiesi Farmaceutici and Windtree Therapeutics are driving market growth with advanced surfactant products.
  • Future Outlook: The market will continue to be influenced by the development of non-invasive surfactant delivery methods and more effective surfactant formulations.

FAQs

What is SURVANTA used for?

SURVANTA is used to treat Respiratory Distress Syndrome (RDS) in premature infants by reducing the surface tension in the lungs and improving lung compliance and oxygenation.

What are the key clinical trials that have evaluated SURVANTA?

SURVANTA has been evaluated in six single-dose and four multiple-dose randomized, multi-center, controlled clinical trials, as well as several open trials involving thousands of infants.

How does SURVANTA compare to other surfactants?

SURVANTA is particularly effective for infants with less than 32 weeks' gestation. It has been shown to have excellent dynamic surface activity compared to other surfactants like Alveofact[5].

What is the market outlook for the RDS treatment market?

The RDS market is expected to grow at a CAGR of 4.56% from 2024 to 2034, driven by advancements in surfactant therapies and non-invasive ventilation techniques.

Are there any ongoing or planned clinical trials for SURVANTA?

A Phase I/II trial for aerosolized SURVANTA was terminated, but the concept of non-invasive surfactant delivery remains an area of interest for future research.

Sources

  1. RxAbbVie: SURVANTA (beractant) intratracheal suspension - RxAbbVie.
  2. Biospace: Respiratory Distress Syndrome Market to Reach a CAGR of 4.56 during 2024-2034.
  3. Johnson & Johnson: Update on U.S. regulatory review of subcutaneous amivantamab.
  4. Orphanet: Aerosolized Survanta in Neonatal Respiratory Distress Syndrome: Phase I/II Study - US.
  5. LARVOL Sigma: Curosurf (poractant alfa) News - LARVOL Sigma.

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