A randomised, open label 2-way cross-over study to compare the effects of inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on hyperinflation and expiratory flow limitation in moderate to severe chronic obstructive pulmonary disease (COPD).
This study will investigate the contributions of extra-fine glycopyrronium and formoterol (within triple therapy) to improvements in small airway function in COPD patients. This will be achieved by recruiting patients with hyperinflation, and measuring improvements in hyperinflation and expiratory flow limitation as measurements of small airway disease. This study will help understand the mechanisms of action of the bronchodilators within BDP/FF/GB, and potentially encourage treatment of small airway disease in COPD with extra-fine bronchodilator treatments. This trial will be conducted in compliance with the Declaration of Helsinki (1964 and amendments) current Good Clinical Practices and all other applicable laws and regulations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Clinical Trial of an Investigational Medicinal Product (CTIMP)
Clinical Trial of an Investigational Medicinal Product (CTIMP)
The Medicines Evaluation Unit (MEU)
Manchester, United Kingdom
Forced Expired Volume in 1 second (FEV1), L.
To compare the effect of Trimbow and Fostair on FEV1 \[(forced expiratory volume in 1 sec - changes from pre-dose day 1)\].
Time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 minutes, 1, 2, 4, 6, 8, 10 and 12 hours post dose)
Residual Volume (RV), L.
To compare the effect of Trimbow and Fostair on RV \[(residual volume) - changes from pre-dose day 1)\].
Time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 and 12 hours post dose)
Peripheral Respiratory Resistance (R5-R20), kPa/L/s.
Impulse Oscillometry measurement
Time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Expiratory Flow Limitation (Delta X5), kPa/L/s.
Impulse Oscillometry measurement
Time frame: Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Forced Vital Capacity (FVC), L
Spirometry measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Forced Expiratory Flow between 25-75% of FVC (FEF25-75%), L/s
Spirometry measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Resistance at 5Hz (R5), kPa/L/s
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Impulse Oscillometry measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Reactance at 5Hz (X5), kPa/L/s
Impulse Oscillometry measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Resonance Frequency (Fres), Hz
Impulse Oscillometry measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Reactance Area (AX), kPa/L
Impulse Oscillometry measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Total Lung Capacity (TLC), L
Plethysmography measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Functional Residual Capacity (FRC), L
Plethysmography measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Inspiratory Capacity (IC), L
Plethysmography measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Specific Airway Conductance (SGaw), L/s/kPa/L
Plethysmography measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Airway Resistance (Raw), kPa/L/s
Plethysmography measurement
Time frame: Baseline, Pre-dose Day 1 and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)
Forced Expired Volume in 1 second (FEV1), L.
Spirometry measurement
Time frame: Baseline and Day 5 (treatment period 1 & 2 - pre-dose, 30 mins, 1, 2, 4, 6, 8, 10 & 12 hrs post dose)
Residual Volume (RV), L.
Plethysmography measurement
Time frame: Baseline and Day 5 (treatment period 1 & 2 - pre-dose, 1, 2, 4, 8 & 12 hrs post dose)