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Trial record 21 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT02491970
Recruitment Status : Terminated (Difficulty of patients enrollments)
First Posted : July 8, 2015
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Mundipharma Korea Ltd

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone/Formoterol Drug: Fluticasone/Salmeterol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : April 6, 2017
Actual Study Completion Date : May 2017


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 Name: 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 Name: Seretide




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of adverse drug reactions as a measure of safety [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Mundipharma Korea Ltd
ClinicalTrials.gov Identifier: NCT02491970     History of Changes
Other Study ID Numbers: FLT14-KR-401
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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
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
Hormones