Pulmonary Disease, Chronic ObstructivePhase 1NCT02076269
Severe Chronic Obstructive Pulmonary Disease Inhalation Profiles Comparison
A Phase 1 study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
This purpose of this study is to obtain inhalation profiles in subjects with very severe Chronic Obstructive Pulmonary Disease (COPD). This is a study with no investigational medicinal product. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males/females aged 40 years and over, at the time of signing the informed consent.
- A female patient is eligible to participate if she is of: Non child-bearing potential, where females are post-menopausal, defined as 12 months of spontaneous amenorrhea [in questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli international units (MIU)/milliliter (mL) and estradiol <40 picograms (pg)/mL (<147 picomoles [pmol]/Liter [L]) is confirmatory] OR Peri-menopausal or pre-menopausal, and have a negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test, confirmed at screening and at Visit 1, before the computed tomography (CT) scanning is conducted.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Available to complete the study.
- Clinically diagnosed COPD, for at least 6 months prior to screening: very severe COPD as defined by current GOLD guidelines. The following lung function criteria are post bronchodilator: Very severe COPD. Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70%, AND FEV1 <30% predicted at screening.
- Patient is a smoker or an ex smoker with a smoking history of at least 10 pack years (Pack years = (cigarettes per day smoked/20) x number of years smoked)).
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- No history of acute respiratory disease within two weeks prior to inclusion (patients should be back to their usual stable baseline lung function)
- No history of any other inflammatory lung condition. Patients with previous lung cancer can be included as long as this has been fully treated and they have been free of disease for the preceding 5 years.
- No exacerbation of disease requiring hospitalisation within the previous two weeks prior to inclusion (patients should be back to their usual stable baseline lung function)
- Able to withhold from short acting bronchodilators for 6 hours and long acting bronchodilators for 12 hours before the start of the study assessments.
Who cannot join
- A patient that has both asthma and COPD.
- A patient that has a past or present disease, which as judged by the Investigator, may affect patient safety or influence the outcome of the study.
- History of alcohol abuse.
- The patient has had a respiratory tract infection within two weeks of the start of the study (patients should be back to their usual stable baseline lung function)
- The patient has a history of claustrophobia.
- As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the patient unfit for the study.
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- The patient is unable to perform the Inhalation Profile assessments correctly.
- The patient has received an investigational drug or device or participated in any other research trial within 30 days of the start of the study.
- The patient has had any radiological investigations with significant radiation burden (a significant radiation burden defined as International Commission on Radiological Protection (ICRP) category IIb or above: no more than 50 millisievert (mSv) normalised for bodyweight in addition to natural background radiation, in the previous 2 years including the dose from this study).
- The patient is oxygen (O2) dependant at the time of day when the study assessments are being completed.
- Unwillingness or inability to follow any of the procedures outlined in the protocol.
- Patient is kept under regulatory or judicial order in an institution.
- Patient is mentally or legally incapacitated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation Of Very Severe Chronic Obstructive Pulmonary Disease Patients For Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry
This purpose of this study is to obtain inhalation profiles in subjects with very severe Chronic Obstructive Pulmonary Disease (COPD). This is a study with no investigational medicinal product. Each subject will attend the clinic on 2 occasions, initially for a screening visit and then for further assessments if included (Visit 1). The maximum time that a subject may be enrolled in the study is 33 days from the screening visit to follow up.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- No Intervention
- Keywords
- HRCT, Dry Powder Inhaler, COPD, Pharyngometry, Inhalation Profiles
- 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.
No InterventionOther
Patients are receiving no treatment in this study and there is no investigational product involved
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Subjects will receive no treatment in this study. Each subject will attend the clinic on 2 occasions, initially for a screening visit and then for further assessments (Visit 1). Subjects will remain in the study for maximum 33 days from the screening visit to follow up. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhalation profile parameters
Following inhalation profile parameters will be obtained using the inhalation profile recorder: Peak Pressure Drop, Peak Inspiratory Flow Rate (PIFR), Inhaled Volume, Inhalation time, Average Inhalation flow, Acceleration rate
Measured: up to approximately 1 month
Pharyngometry measures
Oropharyngeal dimensions will be measured using following parameters of pharyngometry: Distance, Volume, Average cross sectional area.
Measured: up to approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076269
- Sponsor's protocol ID
- 117178
- Status last verified
- Mar 2014
- First submitted
- 30 Jan 2014
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Prime D, de Backer W, Hamilton M, Cahn A, Preece A, Kelleher D, Baines A, Moore A, Brealey N, Moynihan J. Effect of Disease Severity in Asthma and Chronic Obstructive Pulmonary Disease on Inhaler-Specific Inhalation Profiles Through the ELLIPTA(R) Dry Powder Inhaler. J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):486-97. doi: 10.1089/jamp.2015.1224. Epub 2015 Sep 15.
PubMed 26372467Hamilton M, Leggett R, Pang C, Charles S, Gillett B, Prime D. In Vitro Dosing Performance of the ELLIPTA(R) Dry Powder Inhaler Using Asthma and COPD Patient Inhalation Profiles Replicated with the Electronic Lung (eLung). J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):498-506. doi: 10.1089/jamp.2015.1225. Epub 2015 Sep 15.
PubMed 26372465
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation Of Very Severe Chronic Obstructive Pulmonary Disease Patients For Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry
- ClinicalTrials.gov ID
- NCT02076269
- Acronym / sponsor ID
- 117178
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- HRCT, Dry Powder Inhaler, COPD, Pharyngometry, Inhalation Profiles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Mar 2014 (estimated)
- 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 purpose of this study is to obtain inhalation profiles in subjects with very severe Chronic Obstructive Pulmonary Disease (COPD). This is a study with no investigational medicinal product. Each subject will attend the clinic on 2 occasions, initially for a screening visit and then for further assessments if included (Visit 1). The maximum time that a subject may be enrolled in the study is 33 days from the screening visit to follow up.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: No InterventionSubjects will receive no treatment in this study. Each subject will attend the clinic on 2 occasions, initially for a screening visit and then for further assessments (Visit 1). Subjects will remain in the study for maximum 33 days from the screening visit to follow up. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males/females aged 40 years and over, at the time of signing the informed consent.
- A female patient is eligible to participate if she is of: Non child-bearing potential, where females are post-menopausal, defined as 12 months of spontaneous amenorrhea [in questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli international units (MIU)/milliliter (mL) and estradiol <40 picograms (pg)/mL (<147 picomoles [pmol]/Liter [L]) is confirmatory] OR Peri-menopausal or pre-menopausal, and have a negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test, confirmed at screening and at Visit 1, before the computed tomography (CT) scanning is conducted.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Available to complete the study.
- Clinically diagnosed COPD, for at least 6 months prior to screening: very severe COPD as defined by current GOLD guidelines. The following lung function criteria are post bronchodilator: Very severe COPD. Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70%, AND FEV1 <30% predicted at screening.
Key exclusion criteria (13 listed)
- A patient that has both asthma and COPD.
- A patient that has a past or present disease, which as judged by the Investigator, may affect patient safety or influence the outcome of the study.
- History of alcohol abuse.
- The patient has had a respiratory tract infection within two weeks of the start of the study (patients should be back to their usual stable baseline lung function)
- The patient has a history of claustrophobia.
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 |
|---|---|---|
| No InterventionPatients are receiving no treatment in this study and there is no investigational product involved | Other | Arm 1 |
Primary outcome
Inhalation profile parameters
Time frame: up to approximately 1 month
Following inhalation profile parameters will be obtained using the inhalation profile recorder: Peak Pressure Drop, Peak Inspiratory Flow Rate (PIFR), Inhaled Volume, Inhalation time, Average Inhalation flow, Acceleration rate
Pharyngometry measures
Time frame: up to approximately 1 month
Oropharyngeal dimensions will be measured using following parameters of pharyngometry: Distance, Volume, Average cross sectional area.
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 10 Mar 2014.
- Derived from this study: PubMed 26372467Prime D, de Backer W, Hamilton M, Cahn A, Preece A, Kelleher D, Baines A, Moore A, Brealey N, Moynihan J. Effect of Disease Severity in Asthma and Chronic Obstructive Pulmonary Disease on Inhaler-Specific Inhalation Profiles Through the ELLIPTA(R) Dry Powder Inhaler. J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):486-97. doi: 10.1089/jamp.2015.1224. Epub 2015 Sep 15.
- Derived from this study: PubMed 26372465Hamilton M, Leggett R, Pang C, Charles S, Gillett B, Prime D. In Vitro Dosing Performance of the ELLIPTA(R) Dry Powder Inhaler Using Asthma and COPD Patient Inhalation Profiles Replicated with the Electronic Lung (eLung). J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):498-506. doi: 10.1089/jamp.2015.1225. Epub 2015 Sep 15.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. 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 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Inhalation profile parameters (time frame: up to approximately 1 month). The study lists 2 primary outcomes in all. 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 NCT02076269, which also lists 2 linked publications.
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 10 Mar 2014.