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

• ClinicalTrials.gov Identifier: NCT01345266
• Recruitment Status: Completed
• First Posted: May 2, 2011
• Last Update Posted: June 22, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: October 7, 2010
• First Posted Date: May 2, 2011
• Last Update Posted Date: June 22, 2017
• Actual Study Start Date: February 1, 2010
• Actual Primary Completion Date: June 28, 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2011)

• 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 ]
  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
• Pharangometry: Measures will be, Distance (cm) Volume (cm3) Average cross sectional area (cm2) [ Time Frame: 24 hours ]
  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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 28, 2011)

• HRCT scans: Measures are Total Lung Capacity (TLC) and Functional Residual capacity (FRC) [ Time Frame: 24 hours ]
  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.
• Lung function indices by spirometry: Measures, FEV1, Vmax25 and 50, PEFR, PIFR [ Time Frame: 24 hours ]
  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.
• 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. [ Time Frame: 24 hours ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry
• Official Title: Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Pulmonary Disease, Chronic Obstructive

Intervention

Procedure: Inhalation Profiling

All subects recieve Inhaltion Profiling there are no interventions.

Study Arms

Inhalation Profiling

All subjects have Inhaltion profiling, there are no other arms.

Intervention: Procedure: Inhalation Profiling

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 28, 2011): 106
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 28, 2010
• Actual Primary Completion Date: June 28, 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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
• 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

Exclusion Criteria:

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.
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01345266
• Other Study ID Numbers: 113817
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: GlaxoSmithKline
• Original Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
• Current Study Sponsor: GlaxoSmithKline
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: June 2017