Study of PUR118 in Subjects with Cystic Fibrosis.

• Research type

  Research Study

• Full title

  A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of PUR118 and Placebo in Subjects with CF.

• IRAS ID

  94677

• Contact name

  Stephen Smith

• Sponsor organisation

  Pulmatrix, Inc

• Eudract number

  2011-005492-16

• Research summary

  PUR118 is an inhaled therapy which is expected to reduce the severity of acute exacerbations in COPD and Cystic Fibrosis (CF) patients.The active portion of PUR118 is the calcium ion. This is a constituent part of calcium lactate. PUR118 is called a "calcium lactate inhalation powder" (CLIP) formulation. It will be administered by inhalation using a capsule based dry powder inhaler. Data in previous non-human studies suggest that CLIP formulations such as PUR118 alter the properties of airway lininflud to delay or prevent the initiation of infections in the lung. PUR118 may reduce the severity of acute exacerbations in COPD and CF. This may have beneficial impacts on mortality, morbidity and quality of life in affected individuals.

• REC name

  HSC REC B

• REC reference

  11/NI/0172

• Date of REC Opinion

  5 Jan 2012

• REC opinion

  Further Information Favourable Opinion