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