Inhalation Profiling of Idiopathic Pulmonary Fibrosis (IPF) Patients
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|ClinicalTrials.gov Identifier: NCT02058602|
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Other: Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Characterise Lung Function, Airway Morphometry, Pharyngometry and Inhalation Profiles From Patients With Idiopathic Pulmonary Fibrosis (IPF)|
|Actual Study Start Date :||December 3, 2013|
|Actual Primary Completion Date :||July 11, 2016|
|Actual Study Completion Date :||July 11, 2016|
Experimental: Arm 1
This is a clinical study to characterise the lung function, airway morphometry, pharyngometry and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF) over a period of up to 6 months. Approximately 30 subjects will be enrolled so that at least 20 subjects complete all critical assessments.
Other: Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months
Patients are receiving no treatment on this study and there is no investigational product involved.
- To characterise the inhalation profiles [ Time Frame: Up to 6 months ]Inhalation profile was characterised by assessing Peak pressure Drop (kPa), Peak Inspiratory Flow Rate (L/min), Inhaled Volume (L), Inhalation time (s), Average Inhalation Flow Rate (L/min), Acceleration rate (L/min/s)
- To characterise the pharyngometry [ Time Frame: Up to 6 months ]The pharyngometry characters were assessed by Distance (cm), Volume (cm^3), Average cross sectional area (cm^2).
- Mouth and throat measurements from HRCT scan reconstruction [ Time Frame: Up to 6 months ]Mouth and throat measurements from HRCT scan reconstruction assessing Length (mm), Minimum cross-sectional area square millimetre(mm^2), Average cross-sectional area (mm^2), Concavity, Volume (mm^3)
- Lung measurements from HRCT scan [ Time Frame: Up to 6 months ]Lung measurements from HRCT scan by assessing Volume, length, direction and diameter of each airway branch at FRC and TLC, Lobar volumes at FRC and TLC, Relative lobar growth from FRC to TLC, Total lung volume at FRC and TLC
- To explore the relationship between changes in airway morphometry determined by HRCT and measures of spirometry, diffusion and plethysmography [ Time Frame: Up to 6 months ]Lung function by spirometry (FVC, FEV1, Vmax25 and 50, PEFR and PIFR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058602
|GSK Investigational Site|
|Edegem, Belgium, 2650|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|