A scintigraphy study of PT010 in COPD patients

• Research type

  Research Study

• Full title

  A Phase I, Single-Dose, Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI Following a Maximal Breath-Hold of up to 10 s in Patients with Moderate to Severe/Very Severe Chronic Obstructive Pulmonary Disease.

• IRAS ID

  259684

• Contact name

  Ezanul Wahab

• Contact email

  ezanul.wahab@simbec.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2018-004453-25

• Clinicaltrials.gov Identifier

  NCT03906045

• Duration of Study in the UK

  0 years, 10 months, 18 days

• Research summary

  This study is a single treatment period, single dose 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 of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing.

  PT010 is a new combination product 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 a maximal 10 second breath hold, a technique called gamma scintigraphy will be used. Gamma scintigraphy is a technique for detecting and quantifying a radiolabelled tracer inside the body.
  The study will involve the following visits: 1 screening visit, 1 treatment visit, 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 approximately 20 males and females, aged between 40 and 80 years of age with moderate to very severe COPD.
  The purpose of this study is determine if there is a difference in pulmonary deposition between healthy subjects and subjects with COPD as this study has already been conducted in healthy volunteers.

• REC name

  Wales REC 2

• REC reference

  19/WA/0052

• Date of REC Opinion

  21 Feb 2019

• REC opinion

  Further Information Favourable Opinion