A Scintigraphy Study of PT010 in COPD Patients

NCT03906045 | Completed Phase 1

• 1 other identifier: D5980C00020
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; scintigraphy; budesonide; glycopyrronium; formoterol

Outcome Measures

Primary Outcomes (1)

• The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following a maximal breath-hold of up to 10 s.

  Percentage of BGF MDI deposited in the lungs.

  Day 1

Secondary Outcomes (1)

• Regional airway deposition ratios including the non-normalized parameters O/I and C/P regions and the normalized parameters PI and sC/P of the radiolabelled BGF MDI following a maximal breath-hold of up to 10 s.

  Day 1

Other Outcomes (3)

• The fraction of the dose of radiolabelled BGF MDI deposited in the oropharyngeal and stomach regions (expressed as % emitted dose) following a maximal breath-hold of up to 10 s.

  Day 1

• The fraction of the dose of radiolabelled BGF MDI deposited on the actuator (expressed as % ex-valve dose) and exhalation filter (expressed as % emitted dose) following a maximal breath-hold of up to 10 s.

  Day 1

• Adverse Events

  Up to 14 days

Study Arms (1)

All patients

EXPERIMENTAL

10 patients with moderate COPD and 10 patients with severe/very severe COPD inhale BGF followed by a breath hold of up to 10 seconds.

Drug: BGF-MDI

Interventions

BGF-MDI DRUG

Budesonide, Glycopyrronium and Formoterol Fumarate.

All patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females at least 40 years of age and no older than 80 years.
• Patients with diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) \[1\].
• Post bronchodilator (BD) FEV1 / Forced Vital Capacity (FVC) ratio must be \< 0.70.
• Post BD FEV1 must be \< 80% predicted.
• All patients must be receiving 1 or more inhaled maintenance therapies, including at least 1 long-acting bronchodilator, for the management of their COPD for at least 4 weeks prior to the Screening Visit.
• Current or former smokers with a history of at least 10 pack-years of cigarette smoking. \[Number of pack-years = (number of cigarettes per day/20) x number of years smoked (e.g. 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years represent 10 pack-years)\].

You may not qualify if:

• Any significant disease or disorder (e.g. including but not limited to gastrointestinal, hepatic, renal/urinary tract, haematological, neurological, musculoskeletal, endocrine, metabolic, eye, psychiatric which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study.
• Respiratory:
• A moderate or severe exacerbation of COPD ending within 6 weeks prior to dosing (Day 1). The end date of an exacerbation is the last day of treatment with systemic corticosteroids or antibiotics.
• Prior pulmonary resection or Lung Volume Reduction Surgery \[i.e., lobectomy, bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants)\].
• Cardiovascular Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure (including significant cor pulmonale), uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator.
• Current cancer diagnosis requiring treatment.

Sponsors & Collaborators

• AstraZeneca: lead
• Simbec Research: collaborator

Study Sites (2)

Research Site

Llanelli, SA14 8QF, United Kingdom

Location

Research Site

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

Related Publications (1)

• Usmani O, Roche N, Wahab E, Israel S, Jenkins M, Trivedi R, Dorinsky P, Aurivillius M. A scintigraphy study of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2021 Oct 7;22(1):261. doi: 10.1186/s12931-021-01813-w.

  PMID: 34620167 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ezanul Wahab

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 8, 2019
• Study Start: April 4, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

GB (2)