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

GlaxoSmithKline1 site in 1 country106 target enrollmentFebruary 1, 2010

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Enrollment: 106
Locations: 1
Primary Endpoint: 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)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2010

End Date

June 28, 2010

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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.

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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