Effect of Inhaled Mometasone/Formoterol Versus Inhaled Fluticasone/Salmeterol in Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

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.
    

Intervention name(s): Inhaled Mometasone/formoterol; Inhaled Fluticasone/Salmeterol
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled Mometasone/formoterol (100/5 microgram) 2 puffs twice daily via metered dose inhaler for 6 weeks; Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks
Intervention MeSH terms: Fluticasone; Mometasone Furoate; Formoterol Fumarate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Newly diagnosed asthma; peripheral airway function