A study to investigate the lung deposition of a BGF MDI (PT010)

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Two-Period, Single-Dose, Single-Centre, Crossover Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI, Following 3 s and 10 s Breath-Hold, in Healthy Male Subjects

• IRAS ID

  245932

• Contact name

  Samuel Israel

• Contact email

  samuel.israel@covance.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2018-000908-42

• Duration of Study in the UK

  0 years, 2 months, 13 days

• Research summary

  This study is a 2 treatment period, single dose crossover, gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler.

  This study will be investigating how the drug (known as PT010) is distributed in the lungs following a 10 second or 3 second breath hold. This inhaler is intended to be used in the treatment of Chronic Obstructive Pulmonary Disease (COPD), which is a group of diseases which cause lung problems and difficulty breathing.

  PT010 contains a combination of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
  Budesonide is a corticosteroid that works by preventing inflammation and thus can aid in respiratory diseases such as chronic obstructive pulmonary disease. Glycopyrronium & Formoterol Fumarate are bronchdilators which act by relaxing the smooth muscle cells in the trachea and bronchi, allowing greater airflow into the lungs.

  To enable us to determine how much of the drug gets into the lungs following different lengths of breath hold, a technique called gamma scintigraphy will be used. Gamma scintigraphy is a technique used to track the movement of a radiolabelled tracer inside the body.

  By assessing the amount of PT010 in the lungs following different lengths of breath hold, it is intended that this information will provide guidance as to the most effective way of taking the inhaler.

  The study will involve the following visits: 1 screening visits, 2 treatment visits, each separated by around 7 days (each with 1 overnight stay; from the evening before dosing until a minimum of 4 hours post-dose on the morning of
  Day 1) and a post-study follow up phone call.

  The study population will be 10 healthy males, aged between 28 and 50 years of age.

• REC name

  Wales REC 1

• REC reference

  18/WA/0135

• Date of REC Opinion

  22 May 2018

• REC opinion

  Further Information Favourable Opinion