Airway Effects of Tiotropium in Patients With COPD
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|ClinicalTrials.gov Identifier: NCT02683668|
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD LUNG DISEASES, OBSTRUCTIVE||Combination Product: Handihaler-Tiotropium 18 mcg untrained Combination Product: Handihaler-Tiotropium 18 mcg trained Combination Product: Respimat-Tiotropium 5 mcg trained||Phase 3|
Patients with asthma and chronic obstructive airways disease (COPD) undergo routine testing of their lung function in the diagnosis, progression, management and, response to treatment of their disease. Standard lung function obtains measurements based on the forced flow of air moving within the airways. Such measurements give a reasonable assessment of disease affecting the large airways, but not an accurate estimate of small airways disease. Small airways are less than 2mm in diameter. However, both asthma and COPD have disease that involves not only the large but also the small airways that has important clinical consequences. Indeed, COPD predominantly affects the small airways.
Tiotropium (Spiriva, Boehringer Ingelheim), a long-acting inhaled anticholinergic bronchodilator, improves lung function, quality of life, and exercise endurance and reduces exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Respimat Soft MistTM Inhaler (SMI) is a novel inhaler delivering a unique slow-moving Soft MistTM that allows gentle inhalation - making it easy to inhale. Importantly it has drug particles that are ~ 2microns that allow an increase in the total lung deposition of drug (~52%) and also the potential for penetration to treat the small and large airways in patients with COPD; that is targeting the whole airway tree.
RESEARCH AIM & HYPOTHESIS The aim is to investigate the effect of tiotropium from different devices on a panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with mild-moderate COPD. The investigators will compare Tiotropium Handihaler 18 micrograms once daily with Tiotropium Respimat 5 micrograms once daily.
The investigators will identify a COPD cohort with ongoing symptoms or exercise limitation on HandiHaler, as proposed. The science behind this is why are people still limited (even if partially as determined using the CAT score) and is more distal airway targeting necessary? This doesn't necessarily mean targeting the acinar/alveolar beyond the terminal bronchioles, but just a little bit deeper into the distal conducting airway. This can be achieved with Respimat.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Each volunteer get all treatment in a same sequence|
|Masking:||None (Open Label)|
|Official Title:||Targeting of the Small Airways in Patients With COPD: Airway Effects of Tiotropium - Respimat vs Handihaler|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||January 1, 2018|
Experimental: Handihaler-Tiotropium 18 mcg untrained
Patients receiving Handihaler who have not been trained (real-life use) for over 3 months on its use. Here the investigators want to see that if patients have on-going symptoms but are on Handihaler-Tiotropium 18mcg what is happening PRIOR to proper inhaler technique training - that is their 'real-life' use of the inhaler - to their lung function (large and small airways) and also symptoms or exercise limitation (determined by CAT score) will already be recorded as entry criteria
Combination Product: Handihaler-Tiotropium 18 mcg untrained
We are looking at the untrained used of Handihaler
Experimental: Handihaler-Tiotropium 18 mcg trained
Patients will be trained in their use of Handihaler-Tiotropium and asked to take 18 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER proper inhaler technique training on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score)
Combination Product: Handihaler-Tiotropium 18 mcg trained
We are looking at the trained use of Handihaler after 14 days treatment
Experimental: Respimat-Tiotropium 5 mcg trained
Patients will be switched to trained Respimat Tiotropium 5 mcg once daily for 14 days to see if their (i) airway lung function and or (ii) clinical symptoms improve. Here the investigators want to see what happens AFTER this efficient device Respimat (trained) compared to PREVIOUS device Handihaler (trained) on large and small airways lung function and also symptoms or exercise limitation (determined by CAT score). The investigators want to see if the properties of the Respimat device with deeper lung deposition (slow velocity and small particles) can improve small airway measures (and indeed large airway measures) that might also be related to an improvement in symptoms.
Combination Product: Respimat-Tiotropium 5 mcg trained
we are looking at the trained use of Respimat after 14 days treatment
- Peripheral Airways Resistance (R5-R20) [ Time Frame: 6 months ]Peripheral airways resistance measured by impulse oscillometry (IOS). Specific frequencies relate to different levels: a frequency of 5 hertz (Hz) provides values for total airway resistance (R5) and reactance (X5); a 20Hz frequency gives a value for central or large airway resistance (R20); and if one subtracts the value of central airway resistance from that for total airway resistance (i.e. R5-R20), this provides a measure of peripheral or small airways resistance.
- Sacin [ Time Frame: 14 days ]After treatment Impulse Oscillometry parameter. Sacin is a gas exchange measures, assessing convectional ventilation heterogeneity in pre acinar/acinar airways.
- Lung Function FEV1 [ Time Frame: 14 days ]After treatment period the lung function parameters FEV1
- Multi-Breath Washout Test (MBW), Scond [ Time Frame: 14 days ]After the treatment period the MBW parameters. Scond is a gas exchange measures, assessing convectional ventilation heterogeneity in peripheral conducting airways.
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): NCT02683668
|Asthma Lab, Royal Brompton Hospital|
|London, United Kingdom, SW36LY|
|Principal Investigator:||Omar Usmani||Imperial College London|