Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics (MAN05)
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|ClinicalTrials.gov Identifier: NCT02682862|
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : April 22, 2019
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 Withdrawn subjects may be replaced.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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg Drug: olodaterol 2.5 mcg||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Ultra-long Acting Bronchodilator Therapy Assessed by Impulse Oscillometry in Smoking Asthmatics Taking Inhaled Corticosteroids|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Spiolto Respimat
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
Drug: olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg
Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily
Other Name: Spiolto Respimat 2.5mcg/2.5mcg
Active Comparator: Striverdi Respimat
olodaterol 2.5mcg 2 puffs OD (once daily) for 2-4 weeks. Participants then enter washout period and receive alternative treatment arm
Drug: olodaterol 2.5 mcg
Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily
Other Name: Striverdi Respimat 2.5mcg
- Airway resistance at 5Hz (R5) [ Time Frame: 2-4 weeks ]measured by Impulse oscillometry (IOS)
- RF [ Time Frame: 2-4 weeks ]Impulse Oscillometry: Resonant Frequency
- X5 [ Time Frame: 2-4 weeks ]Impulse Oscillometry: Reactance at 5Hz
- AX [ Time Frame: 2-4 weeks ]Impulse Oscillometry: Reactance Area
- R5-R20 [ Time Frame: 2-4 weeks ]Impulse Oscillometry: Resistance at 5Hz minus Resistance at 20Hz, equating to small airway resistance
- R20 [ Time Frame: 2-4 weeks ]Impulse Oscillometry: Resistance at 20Hz
- FEF25-75 pre and post challenge [ Time Frame: 2-4 weeks ]Spirometry: Forced expiratory flow 25%-75% pre and post bronchial challenge (assessing change)
- FVC pre and post challenge [ Time Frame: 2-4 weeks ]Spirometry: Forced vital capacity pre and post bronchial challenge (assessing change)
- FEV1 pre and post challenge [ Time Frame: 2-4 weeks ]Spirometry: Forced expiratory volume in 1 second pre and post bronchial challenge (assessing change)
- Mannitol PD30 [ Time Frame: 2-4 weeks ]Provocation dose of mannitol causing 30% increase in R5
- Mannitol RDR [ Time Frame: 2-4 weeks ]Response-Dose Ratio
- R5 at PD30 [ Time Frame: 2-4 weeks ]Airway Resistance at 5 Hertz at PD30
- Salbutamol recovery time following mannitol challenge [ Time Frame: 2-4 weeks ]
- Domiciliary PEF [ Time Frame: 2-4 weeks ]Peak Expiratory Flow
- ACQ [ Time Frame: 2-4 weeks ]Asthma Control Questionnaire
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): NCT02682862
|Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Principal Investigator:||Sunny Jabbal, Mb Chb||University of Dundee|
|Principal Investigator:||Brian Lipworth, MD, Mb Chb||University of Dundee|