A Scintigraphy Study of PT010 in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

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 (BGF-MDI). 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.
    

Detailed description: 
      This will be a single-dose study to assess the pulmonary deposition of Radiolabelled BGF MDI
      following administration in male and female patients with moderate to severe/very severe
      COPD. Serious Adverse Events (SAEs) will be recorded from the time of signing of informed
      consent form to Post-study Follow-up phone call. Non-serious Adverse Events (AEs) will be
      collected from the first dose on Day 1 to Post-study Follow-up phone call. Study drug will be
      administered by inhalation.

      The study will comprise of a Screening Visit, followed by a single Treatment Period and a
      Post-study Follow-up phone call. The Treatment Period will be from the afternoon before (Day
      1) until 4 hours (h) post dose (Day 1). Patients will arrive at the Clinical Unit on Day 1.
      Patients will withhold their regular COPD medication in the morning of Day 1 and instead be
      given short-acting Ventolin Hydrofluoroalkane (HFA) and Atrovent HFA which may be used up to
      (but not within) 6 h prior to dosing. Investigational Product (IP) will be administered on
      the afternoon of Day 1 fasted (after a fast of at least 2 h) and patients will be discharged
      4 h post dose (Day 1), provided there are no ongoing safety concerns. During the treatment
      period, patients will also undergo a Krypton-81m (81mKr) gas ventilation imaging scan and a
      Cobalt-57 (57Co) transmission scan. SAEs will be evaluated from the time of signing the
      informed consent form and up to the Post-study Follow-up phone call, non-serious AEs will be
      evaluated from Day 1 following IP dose and up to the Post-study Follow-up phone call.
      Approximately 20 patients (10 per cohort) will be enrolled for at least 16 to complete the
      study:

        -  Approximately 10 patients with moderate COPD (Forced Expiratory Volume in 1 Second
           (FEV1) ≥50-<80% of predicted normal), for at least 8 completed patients.

        -  Approximately 10 patients with severe/very severe COPD (FEV1 <50% of predicted normal),
           for at least 8 completed patients.

      At the time of dosing, patients will be required to perform 2 inhalations (after priming)
      under the supervision of an Investigator. Immediately following each inhalation, patients
      will perform a maximal breath-hold, up to 10 s, prior to exhaling into an exhalation filter.
      Once the second breath hold and exhalation has been performed, patients will rinse their
      mouth with water and expel the washings for collection. Patients will then swallow bread and
      water.

      Thereafter, posterior and anterior views of the lungs and stomach, and a lateral head and
      neck view will be recorded using a gamma camera. All images will be of a maximum of 200 s in
      duration. Images will also be acquired of the exhalation filter and collected mouth washings.
      Mass balance calculations will be undertaken to determine the fraction of the emitted dose
      delivered to the lungs of the patients. The distribution pattern of radiolabel within the
      lungs will be described in terms of a ratio of radioactive counts in different lung regions,
      after accounting for differences in regional lung volumes.
    

Intervention name(s): BGF-MDI
Intervention type(s): Drug
Intervention description(s): Budesonide, Glycopyrronium and Formoterol Fumarate.
Intervention model: Single Group Assignment
Intervention model description: This will be a single-dose study to assess the pulmonary deposition of Radiolabelled BGF MDI following administration in male and female patients with moderate to severe/very severe COPD. SAEs will be recorded from the time of signing of informed consent form to Post-study Follow-up phone call. Non-serious AEs will be collected from the first dose on Day 1 to Post-study Follow-up phone call. Study drug will be administered by inhalation.
The study will comprise of a Screening Visit, followed by a single Treatment Period and a Post-study Follow-up phone call.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; scintigraphy; budesonide; glycopyrronium; formoterol