Small Airway Function of Fluticasone/Formoterol (Flutiform®) and Fluticasone/Salmeterol (RECONFFIRM)

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

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: Fluticasone/Formoterol; Drug: Fluticasone/Salmeterol

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult (over 19 years) asthma patients
2. Patients who have a history of mild-to-moderate-severe, persistent asthma for at least 6 months prior to Screening.
3. 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).
4. 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
5. Patients who have uncontrolled asthma by Seretide® 250/50 defined as ACT less than 20
6. Patients who showed R5-20 more than 0.1 kPa/L/s
7. Blood eosinophil count > 300/µL on screening visit
8. Female patients of childbearing potential must have a negative urine pregnancy test at Screening.
9. Patients who are able to use the inhaler
10. Patients who is willing to voluntarily sign the study consent form

Exclusion Criteria:

1. 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
2. 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)
3. 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

4. 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)
5. Patients who currently are pregnant or lactating
6. Patient who had taken systemic corticosteroid within 4 weeks prior to screening
7. Patients who had taken omalizumab within 24 weeks prior to screening

8. Patients who had taken the following medications within 1 week prior to screening:

   • potent CYP3A inhibitors
   • β-blockers
   • monoamine oxidase inhibitor
   • TCA (tricyclic antidepressants)
   • quinidine-type anti arrhythmic
   • Leukotriene anatagonist
   • Astemizole
9. Patients who are participating or going to participate in any interventional clinical trials
10. QT interval prolongation in ECG result at screening
11. Patients with hypersensitive to investigational products or to any component of the drug
12. Patients who are judged difficult to participate in this investigation by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluticasone/Formoterol; Brand name: Flutiform Dose: 250/10μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation	Drug: Fluticasone/Formoterol; Other Names: Flutiform
Active Comparator: Fluticasone/Salmeterol; Brand name: Seretide Dose: 250/50μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation	Drug: Fluticasone/Salmeterol; Other Names: Seretide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy superiority as measured by Impulse Oscillometric System	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse drug reactions as a measure of safety	12 weeks

Collaborators and Investigators

• Sponsor: Mundipharma Korea Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2015
• Primary Completion (Actual): April 6, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: July 3, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Sympathomimetics; Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate
• Other Study ID Numbers: FLT14-KR-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO