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

Asthma Clinical Trial

— RECONFFIRM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02491970
• Other study ID #: FLT14-KR-401
• Status: Terminated
• Phase: Phase 4
• Start date: August 31, 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2018
• Source: Mundipharma Korea Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2017
• Est. primary completion date: April 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

• ß-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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone/Formoterol

• Fluticasone/Salmeterol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Korea Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of adverse drug reactions as a measure of safety		12 weeks