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Pulmonary Disease, Chronic ObstructivePhase 1NCT01345266

Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry

A Phase 1 study testing Inhalation Profiling in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a clinical study, with no investigational product, to characterise the inhalation profiles of healthy volunteers, volunteers with mild, moderate and severe Asthma and volunteers with mild, moderate and severe Chronic Obstructive Pulmonary Disease (COPD), through the novel dry powder inhaler. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Inhalation Profiling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
2 sitesBelgium
Study dates
1 Feb 2010to 28 Jun 2010
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 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply.
  • All volunteers must be aged between 21 to 70 years inclusive and be competent to understand and give informed consent.
  • All female volunteers of child bearing potential must have provided a negative pregnancy test before inclusion and prior to any HRCT scan.
  • Body weight < 120 kg and BMI within the range 18 - 35 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Available to complete the study
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  • Subject will then be included only if they fulfil all criteria for the following relevant cohort Healthy: Cohort
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history and physical. A subject with a clinical abnormality or parameters outside the reference range for the population being studied may be included if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Non-smokers (never smoked or not smoking for >12 months with <1 pack year history) (Pack years = (cigarettes per day smoked/20) x number of years smoked))
  • No history of a chronic respiratory disorder.
  • No history of acute respiratory disease within four weeks prior to inclusion.
  • No history of breathing problems such as a history of asthma, unless the asthma was in childhood and has now completely resolved, no longer requiring maintenance or intermittent therapy.
  • No other significant medical disorder that may affect the respiratory system or that causes significant disability.
  • Asthmatic: Cohort
  • Clinically diagnosed with asthma, for at least 6 months, stratified as either: mild, moderate or severe, based on current treatment, using the British Thoracic Society - - Guidelines on Asthma [BTS, 2009]. For inhaled steroid equivalence to budesonide please refer to the GINA guidelines [GINA, 2008]
  • Mild, defined Step 1 or 2 by BTS Asthma Guidelines
  • Moderate, defined as step 3 by BTS Asthma Guidelines
  • Severe, defined as step 4 or 5 by BTS Asthma Guidelines
  • Non-smokers (never smoked or not smoking for >12 months with <1 pack year history (Pack years = (cigarettes per day smoked/20) x number of years smoked))
  • Able to withhold from short acting bronchodilators for 6 hours and long acting bronchodilators for 12 hours before study assessments
  • No history of acute respiratory disease within four weeks prior to inclusion.
  • No history of any other inflammatory lung condition or carcinoma of the lung.
  • No exacerbation of disease requiring hospitalisation within previous four weeks.
  • COPD: Cohort
  • Clinically diagnosed COPD, for at least 6 months prior to screening, either: mild, moderate or severe/very severe (stage I, II, III/IV) COPD as defined by GOLD guidelines [GOLD 2008]. The following lung function criteria are post bronchodilator
  • Stage I:
  • Mild COPD. FEV1/FVC < 70%, FEV1 ≥ 80% predicted with or without chronic symptoms (cough, sputum production) Stage II
  • Moderate COPD. FEV1/FVC < 70%. 50% ≤ FEV1 < 80% predicted with or without chronic symptoms (cough, sputum production) Stage III and IV
  • Severe COPD. FEV1/FVC < 70%. 30% ≤ FEV1 < 50% predicted with or without chronic symptoms (cough, sputum production)
  • Very Severe COPD.FEV1/FVC < 70%, FEV1 < 30% predicted or FEV1 < 50% predicted plus chronic respiratory failure
  • Subject 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)).
  • No history of acute respiratory disease within four weeks prior to inclusion
  • No history of any other inflammatory lung condition or carcinoma of the lung.
  • No exacerbation of disease requiring hospitalisation within previous four weeks.
  • Able to withhold from short acting bronchodilators for 6 hours and long acting bronchodilators for 12 hours before study assessments

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
  • Any pregnant female
  • Volunteers who have a past or present disease, which as judged by the Investigator, may affect subject safety or influence the outcome of the study.
  • The subject has received an investigational drug or participated in any other research trial within 30 days or five half-lives, or twice the duration of the biological effect of any drug (whichever is longer).
  • The subject that has both asthma and COPD.
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  • Previous inclusion in a research and/or medical protocol involving nuclear medicine,
  • Any Radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv in addition to natural background radiation, in the previous 3 years including the dose from this study).
  • The subject has a history of alcohol or drug abuse.
  • The subject has had a respiratory tract infection within four weeks of the start of the study.
  • The subject has a history of claustrophobia.
  • The subject is unable to perform the Multi Channel Recorder and/or Pharyngometry assessments correctly.
  • The subject has a known allergy or hypersensitivity to milk protein.
  • Unwillingness or inability to follow any of the procedures outlined in the protocol.
  • Subject is kept under regulatory of judicial order in an institution.
  • Subject is mentally or legally incapacitated.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • GSK Investigational Site

    Antwerp, 2060

  • GSK Investigational Site

    Edegem, 2650

Other trials in Belgium

About this study

This is a clinical study, with no investigational product, to characterise the inhalation profiles of healthy volunteers, volunteers with mild, moderate and severe Asthma and volunteers with mild, moderate and severe Chronic Obstructive Pulmonary Disease (COPD), through the novel dry powder inhaler.

Being tested
Inhalation Profiling
Keywords
Pharyngometry, Novel Dry Powder Inhaler, HRCT, 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.

  • Inhalation ProfilingProcedure or surgery

    All subects recieve Inhaltion Profiling there are no interventions.

Study groups in NCT01345266
Study groupRoleWhat they receive
Inhalation ProfilingOtherAll subjects have Inhaltion profiling, there are no other arms.
Receives: Procedure: Inhalation Profiling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inhaltion Profile Recording (IPR): Measures will be Peak Pressure Drop (kPa), Peak Inspiratory Flow Rate (L/min), Inhaled Volume (L), Inhalation time (s) Average Inhalation flow rate (L/min)

    To characterise the inhalation profiles of healthy volunteers, volunteers with mild, moderate and severe asthma and volunteers with mild, moderate and severe COPD, through the novel DPI, using the IPR

    Measured: 24 hours

  2. Pharangometry: Measures will be, Distance (cm) Volume (cm3) Average cross sectional area (cm2)

    To characterise the inhalation profiles of healthy volunteers, volunteers with mild, moderate and severe asthma and volunteers with mild, moderate and severe COPD, using pharangometry

    Measured: 24 hours

Secondary outcomes (3)

  1. HRCT scans: Measures are Total Lung Capacity (TLC) and Functional Residual capacity (FRC)

    Exploratory: To provide data from HRCT scans, spirometry and plethysmography measures which will enable further work in the mapping of the small and large airways and deliver 3D geometries of these airways.

    Measured: 24 hours

  2. Lung function indices by spirometry: Measures, FEV1, Vmax25 and 50, PEFR, PIFR

    Exploratory: To provide data from HRCT scans, spirometry and plethysmography measures which will enable further work in the mapping of the small and large airways and deliver 3D geometries of these airways.

    Measured: 24 hours

  3. Whole body plethysmography: Measures include.Volume: total lung, residual volume, functional reserve volume, Impedance - generation 0 to 6, Resistance - generation 0 to 6 and Diffusion.

    Exploratory: To provide data from HRCT scans, spirometry and plethysmography measures which will enable further work in the mapping of the small and large airways and deliver 3D geometries of these airways.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2011 (estimated)
  2. Study start1 Feb 2010
  3. Primary completion28 Jun 2010
  4. Study completion28 Jun 2010

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345266
Sponsor's protocol ID
113817
Status last verified
Jun 2017
First submitted
7 Oct 2010
Last updated
22 Jun 2017
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 26372467

  • Hamilton 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Inhalation Profiling in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 sites 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 35 inclusion and 16 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 22 Jun 2017. 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 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?

Inhaltion Profile Recording (IPR): Measures will be Peak Pressure Drop (kPa), Peak Inspiratory Flow Rate (L/min), Inhaled Volume (L), Inhalation time (s) Average Inhalation flow rate (L/min) (time frame: 24 hours). 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 NCT01345266, 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 22 Jun 2017.

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