Chronic Obstructive Pulmonary DiseasePhase 1RD708/34000NCT03906045
A Scintigraphy Study of PT010 in COPD Patients
A Phase 1 study testing BGF-MDI in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BGF-MDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Apr 2019to 5 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- 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)].
Main Exclusion Criteria:
- 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:
Current diagnosis of asthma, in the opinion of the Investigator. COPD due to α1-Antitrypsin Deficiency. Sleep apnoea that, in the opinion of the Investigator, is uncontrolled. Other Respiratory Disorders: known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution computerised tomography [CT] evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease. Note: allergic rhinitis is not exclusionary.
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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Research Site
Llanelli, SA14 8QF
Research Site
Merthyr Tydfil, CF48 4DR
About this study
Official title: A Phase I, Single-Dose, Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI in Patients With Moderate to Severe/Very Severe COPD.
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BGF-MDI
- Keywords
- COPD, scintigraphy, budesonide, glycopyrronium, formoterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGF-MDIDrug
Budesonide, Glycopyrronium and Formoterol Fumarate.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BGF-MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Percentages of BGF MDI deposited in different regions of lungs.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start4 Apr 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Ezanul Wahab, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906045
- Sponsor's protocol ID
- D5980C00020
- Acronym
- RD708/34000
- Status last verified
- Feb 2021
- First submitted
- 25 Mar 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34620167
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Dose, Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI in Patients With Moderate to Severe/Very Severe COPD.
- ClinicalTrials.gov ID
- NCT03906045
- Acronym / sponsor ID
- RD708/34000 / D5980C00020
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, scintigraphy, budesonide, glycopyrronium, formoterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: BGF-MDI10 patients with moderate COPD and 10 patients with severe/very severe COPD inhale BGF followed by a breath hold of up to 10 seconds. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGF-MDIBudesonide, Glycopyrronium and Formoterol Fumarate. | Drug | All patients |
Primary outcome
The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following a maximal breath-hold of up to 10 s.
Time frame: Day 1
Percentage of BGF MDI deposited in the lungs.
1 secondary outcome
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.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 34620167Usmani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezanul Wahab principal investigator
Simbec Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGF-MDI in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following a maximal breath-hold of up to 10 s. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.