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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: Inhaled Fluticasone/Salmeterol; Drug: Inhaled Mometasone/formoterol

• Registration Number: NCT02415179
• Lead Sponsor: Mahidol University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-14
• Study Start: 2015-05
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled Fluticasone/Salmeterol	Inhaled Fluticasone/Salmeterol	Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks
Inhaled Mometasone/formoterol	Inhaled Mometasone/formoterol	Inhaled Mometasone/Formoterol (100/5 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks

Primary Outcome Measures

Name	Time	Method
Peripheral airway function measured by impulse oscillometry	6 weeks	The measuring of airway resistance at 5 and 20 Hz

Secondary Outcome Measures

Name	Time	Method
Asthma control questionnaire-7 version	6 weeks	Asthma control questionnaire-7 version
Peak expiratory flow rate	6 weeks	Peak expiratory flow rate
Forced expiratory volume at 1 second	6 weeks	Forced expiratory volume at 1 second
Forced expiratory flow rate at 25-75% of vital capacity	6 weeks	Forced expiratory flow rate at 25-75% of vital capacity
Forced vital capacity	6 weeks	Forced vital capacity
Asthma control test score	6 weeks	Asthma control test score

Trial Locations

Locations (1)

Faculty of Medicine, Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand