Airway Effects of Tiotropium in Patients With COPD
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|ClinicalTrials.gov Identifier: NCT02683668|
Recruitment Status : Unknown
Verified August 2016 by Imperial College London.
Recruitment status was: Recruiting
First Posted : February 17, 2016
Last Update Posted : November 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|COPD LUNG DISEASES, OBSTRUCTIVE||Device: Handihaler-Tiotropium 18 mcg untrained Device: Handihaler-Tiotropium 18 mcg trained Device: Respimat-Tiotropium 5 mcg trained||Phase 4|
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)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting of the Small Airways in Patients With COPD: Airway Effects of Tiotropium - Respimat vs Handihaler|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
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
Device: 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)
Device: 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.
Device: Respimat-Tiotropium 5 mcg trained
we are looking at the trained use of Respimat after 14 days treatment
- Impulse oscillometry measure of (IOS), R5, R20 & R5-R20 [ Time Frame: Baseline & 3 hours post dose ]The change between airways resistance (R5 & R20) at baseline and 3 hours post dose & between Visit 0 and Visit1 and Visit 2 will be measured.
- Multi−Breath Washout Test (MBW), Sacin, Scond & LCI [ Time Frame: Baseline & 3 hours post dose ]The change between MBW parameters (Scond & Sacin & LCI) at baseline and 3 hours post dose & between Visit 0 and Visit1 and Visit 2 will be measured
- Lung Function (FEV1, FVC, PEF) [ Time Frame: Baseline & 3 hours post dose ]The change between lung function parameters parameters FEV1, FVC & PEF at baseline and 3 hours post dose & between Visit 0 and Visit1 and Visit 2 will be measured
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
|Contact: Omar Usmanifirstname.lastname@example.org|
|Contact: Martyn Biddiscombe, PhDemail@example.com|
|Asthma Lab, Royal Brompton Hospital||Recruiting|
|London, United Kingdom, SW36LY|
|Contact: Omar Dr Usmani 02073518051 firstname.lastname@example.org|
|Contact: Martyn Dr Biddiscombe 02073518053 email@example.com|
|Principal Investigator:||Omar Usmani||Imperial College London|