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Trial record 18 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT02415179
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Inhaled Mometasone/formoterol Drug: Inhaled Fluticasone/Salmeterol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Inhaled Mometasone/Formoterol Versus Inhaled Fluticasone/Salmeterol on Peripheral Airway Function in Asthma Patients
Study Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: Inhaled Mometasone/formoterol
Inhaled Mometasone/Formoterol (100/5 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks
Drug: Inhaled Mometasone/formoterol
Inhaled Mometasone/formoterol (100/5 microgram) 2 puffs twice daily via metered dose inhaler for 6 weeks

Active Comparator: Inhaled Fluticasone/Salmeterol
Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks
Drug: Inhaled Fluticasone/Salmeterol
Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks




Primary Outcome Measures :
  1. Peripheral airway function measured by impulse oscillometry [ Time Frame: 6 weeks ]
    The measuring of airway resistance at 5 and 20 Hz


Secondary Outcome Measures :
  1. Peak expiratory flow rate [ Time Frame: 6 weeks ]
    Peak expiratory flow rate

  2. Forced expiratory volume at 1 second [ Time Frame: 6 weeks ]
    Forced expiratory volume at 1 second

  3. Forced vital capacity [ Time Frame: 6 weeks ]
    Forced vital capacity

  4. Forced expiratory flow rate at 25-75% of vital capacity [ Time Frame: 6 weeks ]
    Forced expiratory flow rate at 25-75% of vital capacity

  5. Asthma control test score [ Time Frame: 6 weeks ]
    Asthma control test score

  6. Asthma control questionnaire-7 version [ Time Frame: 6 weeks ]
    Asthma control questionnaire-7 version



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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

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): NCT02415179


Locations
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Thailand
Faculty of Medicine, Ramathibodi Hospital
Bangkok, Thailand
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: 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

Publications:

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02415179     History of Changes
Other Study ID Numbers: ZS-2015
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Keywords provided by Mahidol University:
Newly diagnosed asthma
peripheral airway function
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids