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

April 25, 2016 updated by: Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Faculty of Medicine, Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral airway function measured by impulse oscillometry
Time Frame: 6 weeks
The measuring of airway resistance at 5 and 20 Hz
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak expiratory flow rate
Time Frame: 6 weeks
Peak expiratory flow rate
6 weeks
Forced expiratory volume at 1 second
Time Frame: 6 weeks
Forced expiratory volume at 1 second
6 weeks
Forced vital capacity
Time Frame: 6 weeks
Forced vital capacity
6 weeks
Forced expiratory flow rate at 25-75% of vital capacity
Time Frame: 6 weeks
Forced expiratory flow rate at 25-75% of vital capacity
6 weeks
Asthma control test score
Time Frame: 6 weeks
Asthma control test score
6 weeks
Asthma control questionnaire-7 version
Time Frame: 6 weeks
Asthma control questionnaire-7 version
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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