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

NCT01345266 | Completed Phase 1

• 1 other identifier: 113817
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pharyngometry; Novel Dry Powder Inhaler; HRCT; Inhalation Profiles

Outcome Measures

Primary Outcomes (2)

• 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

  24 hours

• 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

  24 hours

Secondary Outcomes (3)

• 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

Study Arms (1)

Inhalation Profiling

OTHER

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

Procedure: Inhalation Profiling

Interventions

Inhalation Profiling PROCEDURE

All subects recieve Inhaltion Profiling there are no interventions.

Inhalation Profiling

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All volunteers must be aged between 21 to 70 years inclusive and be competent to understand and give informed consent.
• 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 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Antwerp, 2060, Belgium

Location

GSK Investigational Site

Edegem, 2650, Belgium

Location

Related Publications (2)

• 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.

  PMID: 26372467 DERIVED

• 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.

  PMID: 26372465 DERIVED

Related Links

• Results for study 113817 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: May 2, 2011
• Study Start: February 1, 2010
• Primary Completion: June 28, 2010
• Study Completion: June 28, 2010
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

BE (2)