Effect of Inhaled Mometasone/Formoterol Versus Inhaled Fluticasone/Salmeterol in Asthma Patients

Asthma Clinical Trial

Official title:

Effect of Inhaled Mometasone/Formoterol Versus Inhaled Fluticasone/Salmeterol on Peripheral Airway Function in Asthma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415179
• Other study ID #: ZS-2015
• Status: Completed
• Phase: N/A
• First received: January 29, 2015
• Last updated: April 25, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Newly diagnosed asthma according to Global Initiative for Asthma (GINA) guideline 2014 without previous treatment of inhaled corticosteroid and long acting beta agonists

2. Patients with asthma symptoms of most days or wake up due to asthma one time per week or more

3. Patients with the presence of any risk factors of asthma according to Global Initiative for Asthma (GINA) guideline 2014

4. Patients with severe uncontrolled asthma

5. Patients with previous asthma exacerbation

6. Patients give consent form

Exclusion Criteria:

1. Patients with contra-indication for performing spirometry according to American Thoracic Society (ATS) and European Respiratory Society (ERS) statement of standardization for spirometry

2. Patients refuse to participate study -

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Inhaled Mometasone/formoterol
Inhaled Mometasone/formoterol (100/5 microgram) 2 puffs twice daily via metered dose inhaler for 6 weeks
• Inhaled Fluticasone/Salmeterol
Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

Bernstein DI, Hébert J, Cheema A, Murphy KR, Chérrez-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;7:21. doi: 10.1186/1710-1492-7-21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002 Feb;109(2 Suppl):S447-60. Review. — View Citation

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. — View Citation

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. Epub 2005 Sep 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral airway function measured by impulse oscillometry	The measuring of airway resistance at 5 and 20 Hz	6 weeks
Secondary	Peak expiratory flow rate	Peak expiratory flow rate	6 weeks
Secondary	Forced expiratory volume at 1 second	Forced expiratory volume at 1 second	6 weeks
Secondary	Forced vital capacity	Forced vital capacity	6 weeks
Secondary	Forced expiratory flow rate at 25-75% of vital capacity	Forced expiratory flow rate at 25-75% of vital capacity	6 weeks
Secondary	Asthma control test score	Asthma control test score	6 weeks
Secondary	Asthma control questionnaire-7 version	Asthma control questionnaire-7 version	6 weeks