Study to Evaluate Small Airway Parameters of Fluticasone/Formoterol (Flutiform®) Compared to Fluticasone/Salmeterol in Asthma Patients
Information source: Mundipharma Korea Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Fluticasone/Formoterol (Drug); Fluticasone/Salmeterol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mundipharma Korea Ltd Overall contact: Valerie Leck, Email: info.rma@mundipharma.com.sg
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy superiority as measured by Impulse Oscillometric System
Secondary outcome: Incidence of adverse drug reactions as a measure of safety
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Valerie Leck, Email: info.rma@mundipharma.com.sg
Asan Medical Center, Seoul 138736, Korea, Republic of; Recruiting Seiwon Lee, MD
Additional Information
Starting date: June 2015
Last updated: July 3, 2015
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