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Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis — SEADIB1  

Non-cystic Fibrosis Bronchiectasis Clinical Trial

Official title:
Safety, Tolerability and Efficacy of Ultra-low Doses of Alkylating Drug Melphalan Inhalations for the Treatment of Non-cystic Fibrosis Bronchiectasis

Clinical Trial Summary

This non-randomised open-label prospective pilot study evaluates the safety and efficacy of inhalations of ultra-low doses of alkylating drug melphalan for the treatment of non-cystic fibrosis bronchiectasis. All patients will receive 0,1 mg of melphalan in 5 daily inhalations 1 time per day.

Clinical Trial Description

It was previously shown that in ultra-low (more than 100 times lower than conventional therapeutic) doses inhalations of alkylating drug (melphalan) are effective in severe steroid-resistant bronchial asthma, a form of the disease often characterized by neutrophilic type of inflammation. The exacerbation frequency reduced after the treatment, steroid-sparing effect was shown, morphological signs of bronchial epithelial regeneration were revealed and quality of life of asthmatic patients, treated with ultra-low doses of melphalan, improved. In preclinical studies and studies with volunteers, it was found that inhalations of ultra-low doses of melphalan do not have cytotoxic properties, but have local and systemic anti-inflammatory effects and decrease the activation of lymphocytes due to blockade of heavy β-chain of the interleukin (IL)-2 surface receptor. In addition, in ultra-low concentrations, alkylating agents are able to disrupt the cell signalling through the receptor for tumor necrosis factor, thereby exerting a protective effect from the cytotoxic activity of tumor necrosis factor (TNF)-α, which leads to the anti-inflammatory response. It can be assumed that the inhalation use of ultra-low doses of melphalan can be effective in patients with bronchiectasis, as in a disease characterized by a neutrophilic type of inflammation, leading to the improvement of quality of life, increasing the time to the first exacerbation and decreasing of exacerbation frequency. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04278040
Study type Interventional
Source Federal State Budgetary Institution, Pulmonology Scientific Research Institute
Contact Evgeny Sinitsyn
Phone +79269490744
Email sinymlad@list.ru
Status Recruiting
Phase Phase 2
Start date June 20, 2018
Completion date December 30, 2021
View Details
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