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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005317-23 | EudraCT Number |
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Single centre, open-label, random order, cross-over trial, recruited over a period of approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn subjects may be replaced.
This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test called impulse oscillometry.
Cigarette smoking in asthma is associated with poorer asthma control and a higher frequency of asthma attacks. Despite this, smoking cessation rates are very low due to the highly addictive nature of tobacco smoking. Asthma in smokers is particularly challenging to manage because it is resistant to the beneficial effects of inhaled corticosteroids, the main treatment for asthma.
Unfortunately, there is no guideline consensus regarding how to best manage asthmatics who smoke. Research studies in asthma tend to exclude smokers because of concerns about recruiting patients with chronic obstructive pulmonary disease (COPD). Hence, there is an unmet need for research studies in asthmatics who are unable to stop smoking.
In view of the above, we propose to assess the effects of two different types of bronchodilators (inhalers which help open up the airways), in asthmatics who continue to smoke.
Participants will receive both of the following drugs for 2-4 weeks in random order, with a 2-3 week washout period in between:
Olodaterol which is a new long-acting bronchodilator. Olodaterol combined with tiotropium (dual bronchodilators). We wish to compare these inhalers using a sensitive pulmonary function test called impulse oscillometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiolto Respimat | Experimental | olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg 2 puffs OD (once daily) for 2-4 weeks. Participants then enter washout period and receive alternative treatment arm |
|
| Striverdi Respimat | Active Comparator | olodaterol 2.5mcg 2 puffs OD (once daily) for 2-4 weeks. Participants then enter washout period and receive alternative treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg | Drug | Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily |
| Measure | Description | Time Frame |
|---|---|---|
| Airway resistance at 5Hz (R5) | measured by Impulse oscillometry (IOS) | 2-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RF | Impulse Oscillometry: Resonant Frequency | 2-4 weeks |
| X5 | Impulse Oscillometry: Reactance at 5Hz | 2-4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunny Jabbal, Mb Chb | University of Dundee | Principal Investigator |
| Brian Lipworth, MD, Mb Chb | University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School | Dundee | Scotland | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33548471 | Derived | Lipworth B, RuiWen Kuo C, Jabbal S, Chan R. Inhaled triple therapy and airway hyperresponsiveness in persistent asthma. Ann Allergy Asthma Immunol. 2021 May;126(5):597-598. doi: 10.1016/j.anai.2021.01.032. Epub 2021 Feb 3. No abstract available. | |
| 33180376 | Derived | Jabbal S, Kuo CR, Lipworth B. Randomized controlled trial of triple versus dual inhaler therapy on small airways in smoking asthmatics. Clin Exp Allergy. 2020 Oct;50(10):1140-1147. doi: 10.1111/cea.13702. Epub 2020 Jul 27. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| C000611386 | tiotropium-olodaterol |
| C549647 | olodaterol |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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|
| olodaterol 2.5 mcg | Drug | Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily |
|
|
| AX | Impulse Oscillometry: Reactance Area | 2-4 weeks |
| R5-R20 | Impulse Oscillometry: Resistance at 5Hz minus Resistance at 20Hz, equating to small airway resistance | 2-4 weeks |
| R20 | Impulse Oscillometry: Resistance at 20Hz | 2-4 weeks |
| FEF25-75 pre and post challenge | Spirometry: Forced expiratory flow 25%-75% pre and post bronchial challenge (assessing change) | 2-4 weeks |
| FVC pre and post challenge | Spirometry: Forced vital capacity pre and post bronchial challenge (assessing change) | 2-4 weeks |
| FEV1 pre and post challenge | Spirometry: Forced expiratory volume in 1 second pre and post bronchial challenge (assessing change) | 2-4 weeks |
| Mannitol PD30 | Provocation dose of mannitol causing 30% increase in R5 | 2-4 weeks |
| Mannitol RDR | Response-Dose Ratio | 2-4 weeks |
| R5 at PD30 | Airway Resistance at 5 Hertz at PD30 | 2-4 weeks |
| Salbutamol recovery time following mannitol challenge | 2-4 weeks |
| Domiciliary PEF | Peak Expiratory Flow | 2-4 weeks |
| ACQ | Asthma Control Questionnaire | 2-4 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |