SCLEROSOL SUMMARY
SCLEROSOL® INTRAPLEURAL AEROSOL
(sterile talc powder)
NDC No. 63256-100-30
Sclerosol® Intrapleural Aerosol (sterile talc powder 4 g) is a sclerosing agent for intrapleural administration supplied as a single-use, pressurized spray canister with two delivery tubes of 15 cm and 25 cm in length. Each canister contains 4.0 g of talc, either white or off-white to light grey, asbestos-free, and brucite-free grade of talc of controlled granulometry. The composition of the talc is ≥ 95% talc as hydrated magnesium silicate.
Sclerosol® Intrapleural Aerosol, administered by aerosol during thoracoscopy or open thoracotomy, is indicated to prevent recurrence of malignant pleural effusions in symptomatic patients.
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NEWS HIGHLIGHTS
Published Studies Related to Sclerosol (Talc Intrapleural)
A comparison of the effectiveness of talc, polidocanol and ethanol as pleural sclerosing agents in rabbits. [2009.03]
BACKGROUND: Aim of the study was to compare the pleurodesis results from the intrapleural injection of talc, polidocanol and ethanol into the rabbit pleura... CONCLUSION: The intrapleural injection of polidocanol produces better pleurodesis than does the intrapleural injection of talc or ethanol in rabbits. Because of the efficacy of polidocanol as a sclerosing agent, its use in humans should be considered after further animal studies.
Talc pleurodesis: evidence of systemic inflammatory response to small size talc particles. [2009.01]
The mechanisms of the systemic response associated with talc-induced pleurodesis are poorly understood. The aim of this study was to assess the acute inflammatory response and migration of talc of small size particles injected in the pleural space...
Pleural mesothelial cells mediate inflammatory and profibrotic responses in talc-induced pleurodesis. [2007.12]
Intrapleural talc is used to produce pleurodesis in malignant pleural effusions...
Inflammation and clinical repercussions of pleurodesis induced by intrapleural talc administration. [2007.10]
Although reports on pleurodesis date back to the beginning of the 20th century, the search for the ideal sclerosing agent is ongoing... In this article we discuss the likely mechanisms of pleural inflammation and pleurodesis with emphasis on the systemic response due to the instillation of talc into the pleural space.
Inflammation and clinical repercussions of pleurodesis induced by intrapleural talc administration. [2007.10]
Although reports on pleurodesis date back to the beginning of the 20th century, the search for the ideal sclerosing agent is ongoing... In this article we discuss the likely mechanisms of pleural inflammation and pleurodesis with emphasis on the systemic response due to the instillation of talc into the pleural space.
Clinical Trials Related to Sclerosol (Talc Intrapleural)
Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions [Active, not recruiting]
RATIONALE: Some drugs such as bleomycin or doxycycline, or other compounds like talc, may
help to control fluid in the chest caused by cancer. It is not yet known if bleomycin,
doxycycline, or talc is more effective in treating patients with malignant pleural
effusions.
PURPOSE: Randomized phase III trial to compare the effectiveness of bleomycin, doxycycline,
or talc in treating patients with malignant pleural effusions.
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma [Recruiting]
RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of
the chest cavity may be effective in treating pleural effusion and cause less damage to
normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is
not yet known which therapy is more effective in treating pleural effusion caused by
malignant mesothelioma.
PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well
it works compared with talc pleurodesis in treating patients with malignant mesothelioma.
A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis [Recruiting]
Pleurodesis is a technique used to fuse the two layers of the lining over the lung. This is
done to get rid of collections of fluid or air in this space. A common reason would be
cancer of the underlying lung or elsewhere causing fluid to collect in the pleural space.
In this situation it is a palliative procedure to free the patient from symptoms like
breathlessness.
Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC) [Recruiting]
Typically, people with asthma are initially prescribed a low dose of inhaled corticosteroid
(ICS) medication to control asthma symptoms. If a low dose of ICS is ineffective at
controlling symptoms, the addition of a second controller medication is recommended. This
study will examine the effectiveness of the medication tiotropium bromide combined with a low
dose of ICS at maintaining asthma control in people with moderately severe asthma.
Tunneled Pleural Catheter in Partially Entrapped Lung [Not yet recruiting]
An open randomized, prospective, single center; parallel group trial to compare efficiency
and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with
malignant pleural effusion and partial entrapment of the lung.
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