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

NCT02491970 | Terminated Phase 4

• 1 other identifier: FLT14-KR-401
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of adverse drug reactions as a measure of safety

  12 weeks

Study Arms (2)

Fluticasone/Formoterol

EXPERIMENTAL

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

Drug: Fluticasone/Formoterol

Fluticasone/Salmeterol

ACTIVE COMPARATOR

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

Drug: Fluticasone/Salmeterol

Interventions

Fluticasone/Formoterol DRUG

Also known as: Flutiform

Fluticasone/Formoterol

Fluticasone/Salmeterol DRUG

Also known as: Seretide

Fluticasone/Salmeterol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients who had taken the following medications within 1 week prior to screening:
• potent CYP3A inhibitors
• β-blockers
• monoamine oxidase inhibitor
• TCA (tricyclic antidepressants)

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

MeSH Terms

Conditions

Asthma

Interventions

fluticasone-formoterol; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 8, 2015
• Study Start: August 31, 2015
• Primary Completion: April 6, 2017
• Study Completion: May 1, 2017
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share