IPF Drug Deposition Study
Research type
Research Study
Full title
A study of the pharmacokinetics and deposition of inhaled salbutamol in patients with idiopathic pulmonary fibrosis (TOPICAL-IPF Study).
IRAS ID
47938
Contact name
Toby M Maher
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Eudract number
2011-000336-29
ISRCTN Number
not known
Research summary
TITLE: A study of the pharmacokinetics and deposition of inhaled salbutamol in patients with idiopathic pulmonary fibrosis.Idiopathic pulmonary fibrosis is a progressive and invariably fatal lung disease for which no effective treatment exists. It is characterised by progressive fibrosis and destruction of the lung. Medication given directly to the lung (e.g. by inhaler device or nebuliser) is important in the treatment of a number of respiratory diseases such as asthma or emphysema. Because of the changes that occur in the lungs of patients with IPF it is not clear whether it is possible or effective to deliver inhaled medication in patients with this disease. This study aims to evaluate the feasibility of this approach in IPF by using radiolabelling (attaching a radioactive probe to a drug) and imaging of the lungs and by measuring the absorption of the safe and widely used medication, salbutamol. Radio-labelled salbutamol will be administered to study participants on 4 separate occasions via a specially designed inhaler device and thorugh a nebuliser. Images of the lung taken after inhalation of the salbutamol will provide important information on whether the drug reaches areas of scarring and fibrosis.The study will recruit 20 individuals with either moderate or severe IPF. Participation in the study will entail four visits each at least a week apart.It is hoped that this study will pave the way to the development of novel treatments for IPF.
REC name
London - Chelsea Research Ethics Committee
REC reference
11/LO/0372
Date of REC Opinion
8 Jun 2011
REC opinion
Further Information Favourable Opinion