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The purpose of this study is to investigate the effectiveness of inhaled mometasone/formoterol versus inhaled fluticasone/salmeterol on peripheral airway function in treatment of asthma.
Peripheral airway dysfunction is associated with poor asthma outcome including asthma exacerbation and more symptoms. The peripheral or small airway is anatomically defined by airways with 2 mm diameter or less. Several techniques have been used for evaluating peripheral airways such as spirometry, body plethysmography, impulse oscillometry and imaging studies. Since inhaled corticosteroid is corner stone for treatment of asthma, the addition of long acting beta agonist is indicated in severe asthma with poorly controlled disease despite of high dose inhaled corticosteroid.
The inhaled corticosteroid and long acting beta agonists are available for treating asthma. There were different results in comparison studies of different inhaled corticosteroid and long acting beta agonist. These differences are related to type of inhaled formulation, potency of inhaled corticosteroid or dose and outcome measurements. The previous short term studies shown that inhaled budesonide/formoterol is superior to inhaled fluticasone/salmeterol combination for reducing of peripheral airway resistance measured by impulse oscillometry. However, the active drug was delivered by using dry powder inhaler. There is no direct comparison between inhaled mometasone/formoterol and inhaled fluticasone/salmeterol administered using metered dose inhalers. For these reasons, we conduct the open label study comparing the effect of two inhaled corticosteroid and long acting beta agonist in newly diagnosed asthma who are eligible for being treated with such combination therapies.
Eligible patients who have clinically diagnosed asthma requiring treatment with combined inhaled corticosteroid and long acting beta agonist according to Global Initiative for Asthma (GINA) guideline. The patients will be randomized to receive either inhaled mometasone/formoterol (100/5 microgram) 2 puffs twice daily or inhaled fluticasone/salmeterol (125/25 microgram) 2 puffs twice daily administered using metered dose inhalers.
The primary outcome is peripheral airway function measured by airway resistance at 5 and 20 Hz frequency from impulse oscillometry. The secondary outcome are peak expiratory flow rate, forced expiratory flow at 1 second, forced vital capacity, forced expiratory flow at 25-75% of vital capacity (FEF25-75%) measured by spirometry, residual volume per total lung capacity ratio measured by body plethysmography ,asthma control test score and asthma control questionaire-7 version. All outcome are measured at baseline and 6-week post treatments in both arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Mometasone/formoterol | Experimental | Inhaled Mometasone/Formoterol (100/5 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks |
|
| Inhaled Fluticasone/Salmeterol | Active Comparator | Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Mometasone/formoterol | Drug | Inhaled Mometasone/formoterol (100/5 microgram) 2 puffs twice daily via metered dose inhaler for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral airway function measured by impulse oscillometry | The measuring of airway resistance at 5 and 20 Hz | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peak expiratory flow rate | Peak expiratory flow rate | 6 weeks |
| Forced expiratory volume at 1 second | Forced expiratory volume at 1 second |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tananchai Petnak, M.D. | Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University | Principal Investigator |
| Theerasuk Kawamatawong, M.D. | Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University | Principal Investigator |
| Prapaporn Pornsuriyasak, M.D. | Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University | Principal Investigator |
| Viboon Boonsarngsuk, M.D. | Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University | Principal Investigator |
| Naparat Amornputtisathaporn, M.D. | Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Ramathibodi Hospital | Bangkok | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11401872 | Background | Kraft M, Pak J, Martin RJ, Kaminsky D, Irvin CG. Distal lung dysfunction at night in nocturnal asthma. Am J Respir Crit Care Med. 2001 Jun;163(7):1551-6. doi: 10.1164/ajrccm.163.7.2008013. | |
| 11842317 | Background | Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002 Feb;109(2 Suppl):S447-60. doi: 10.1067/mai.2002.121409. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 6, 2016 | |
| Reset | Jan 27, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 6, 2016 | Jan 27, 2017 |
| 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 |
|---|---|
| D000068759 | Formoterol Fumarate |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Inhaled Fluticasone/Salmeterol | Drug | Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks |
|
| 6 weeks |
| Forced vital capacity | Forced vital capacity | 6 weeks |
| Forced expiratory flow rate at 25-75% of vital capacity | Forced expiratory flow rate at 25-75% of vital capacity | 6 weeks |
| Asthma control test score | Asthma control test score | 6 weeks |
| Asthma control questionnaire-7 version | Asthma control questionnaire-7 version | 6 weeks |
| 16192448 | Background | Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28. |
| 21828036 | Background | Meltzer EO, Kuna P, Nolte H, Nayak AS, Laforce C; P04073 Study Investigators. Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function. Eur Respir J. 2012 Feb;39(2):279-89. doi: 10.1183/09031936.00020310. Epub 2011 Aug 4. |
| 25194884 | Background | Kirsten AM, Watz H, Brindicci C, Piccinno A, Magnussen H. Effects of beclomethason/formoterol and budesonide/formoterol fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma--an exploratory study. Pulm Pharmacol Ther. 2015 Apr;31:79-84. doi: 10.1016/j.pupt.2014.08.007. Epub 2014 Sep 4. |
| 22152089 | Background | Bernstein DI, Hebert J, Cheema A, Murphy KR, Cherrez-Ojeda I, Matiz-Bueno CE, Kuo WL, Nolte H. Efficacy and onset of action of mometasone furoate/formoterol and fluticasone propionate/salmeterol combination treatment in subjects with persistent asthma. Allergy Asthma Clin Immunol. 2011 Dec 7;7(1):21. doi: 10.1186/1710-1492-7-21. |
| 21624490 | Background | Hozawa S, Terada M, Hozawa M. Comparison of budesonide/formoterol Turbuhaler with fluticasone/salmeterol Diskus for treatment effects on small airway impairment and airway inflammation in patients with asthma. Pulm Pharmacol Ther. 2011 Oct;24(5):571-6. doi: 10.1016/j.pupt.2011.05.004. Epub 2011 May 23. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |