A Single-blind, Randomized, Active-controlled, Multi-center and Phase IV Study to Evaluate the Small Airway Parameters of Fluticasone/Formoterol (Flutiform®) Compared to Fluticasone/Salmeterol in Asthma Patients

Mundipharma Korea Ltd0 sites15 target enrollmentAugust 31, 2015

ConditionsAsthma

InterventionsFluticasone/Formoterol Fluticasone/Salmeterol

DrugsFluticasone/Formoterol Fluticasone/Salmeterol

Overview

Phase: Phase 4
Intervention: Fluticasone/Formoterol
Conditions: Asthma
Sponsor: Mundipharma Korea Ltd
Enrollment: 15
Primary Endpoint: Efficacy superiority as measured by Impulse Oscillometric System
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate superiority of Fluticasone/Formoterol (Flutiform®) to Fluticasone/salmeterol based on the small airway function by assessing the Impulse Oscillometic System (IOS) in uncontrolled asthma patients requiring ICS/LABA concomitant treatment.

Registry

clinicaltrials.gov

Start Date

August 31, 2015

End Date

May 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mundipharma Korea Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult (over 19 years) asthma patients
•Patients who have a history of mild-to-moderate-severe, persistent asthma for at least 6 months prior to Screening.
•Patients who were required to demonstrate a FEV1 of ≥ 40 % and ≤ 85% of predicted normal values during screening period following appropriate withholding of asthma medications (if applicable).
•Patients who were required to show reversibility of ≥15% FEV1 after salbutamol inhalation (2 actuations, 100µg per actuation) from the pre- salbutamol value at screening
•Patients who have uncontrolled asthma by Seretide® 250/50 defined as ACT less than 20
•Patients who showed R5-20 more than 0.1 kPa/L/s
•Blood eosinophil count \> 300/µL on screening visit
•Female patients of childbearing potential must have a negative urine pregnancy test at Screening.
•Patients who are able to use the inhaler
•Patients who is willing to voluntarily sign the study consent form

Exclusion Criteria

•Patients who have experienced life-threatening asthma within 12 months prior to screening or respiratory infection within 4 weeks prior to screening, or patients who have experienced any emergency visit or hospitalization due to acute asthma symptoms within 4 weeks prior to screening
•Patients who have diagnosed as clinically significant disease or non- reversible pulmonary disease or patients who currently have active pulmonary disease (eg. COPD, cystic fibrosis, bronchiectasis, active tuberculosis)
•Patients who have diagnosed as laryngitis, chronic sinusitis, infectious rhinitis or allergic rhinitis within 4 weeks prior to screening, or patients who have had any symptoms of acute exacerbation or purulent discharge by the disease above within 2 weeks prior to screening
•Current smoker or past smoker defined as below:
•Current smoker: smoking history within 12 months prior to screening
•Past smoker: smoking amount ≥10 pack year\*
•Pack year (PY) calculation: average amount of smoking per day (pack) x duration of smoking (year)
•Patients who currently are pregnant or lactating
•Patient who had taken systemic corticosteroid within 4 weeks prior to screening
•Patients who had taken omalizumab within 24 weeks prior to screening

Arms & Interventions

Fluticasone/Formoterol

Brand name: Flutiform Dose: 250/10μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation

Intervention: Fluticasone/Formoterol

Fluticasone/Salmeterol

Brand name: Seretide Dose: 250/50μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation

Intervention: Fluticasone/Salmeterol

Outcomes

Primary Outcomes

Efficacy superiority as measured by Impulse Oscillometric System

Time Frame: 12 weeks

To compare Fluticasone/Formoterol to Fluticasone/salmeterol, assessing the change in the mean R5-R20 measured by the Impulse Oscillometic System (IOS) in uncontrolled asthma patients