A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

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.

      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.
    

Detailed description: 
      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 bronchodilators 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.
    

Intervention name(s): BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold; BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single dose of BGF MDI; the dose will be administered with a 10 s breath-hold.; Participants will receive a single dose of BGF MDI; the dose will be administered with a 3 s breath-hold.
Other intervention name(s): PT010 with 10 s breath hold; PT010 with 3 s breath hold
Intervention MeSH terms: Budesonide; Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment