Effect of inhalation formulation on uncontrolled asthma

Effect of inhalation formulation on uncontrolled asthma - EFFIE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003864-27-FI

Enrollment

Registered

2019-10-25

Start date

2020-01-22

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 100000004855

Interventions

Trade Name: Flutiform K-haler Product Name: Flutiform K-haler Pharmaceutical Form: Inhalation solution INN or Proposed INN: Fluticasone propionate CAS Number: 80474-14-2 Concentration unit: µg microgr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 12-=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: pregnancy lactation other pulmonary disease than asthma active and uncontrolled cardiovascular or other systemic disease malignancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Our aim is to study the changes of lung function in patients with uncontrolled asthma between study medications fluticasone propionate/formoterol and fluticasone fumarate/vilanterol.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint of this study is: to investigate the change in FEV1 between the two study formulations with fluticasone furoate/vilanterol and fluticasone propionate/formoterol fumarate. ;Timepoint(s) of evaluation of this end point: Baseline-after 8-9 weeks of medication 1-after 8-9 weeks of medication 2	—

Measure

Time frame

Main Objective: Our aim is to study the changes of lung function in patients with uncontrolled asthma between study medications fluticasone propionate/formoterol and fluticasone fumarate/vilanterol.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint of this study is: to investigate the change in FEV1 between the two study formulations with fluticasone furoate/vilanterol and fluticasone propionate/formoterol fumarate. ;Timepoint(s) of evaluation of this end point: Baseline-after 8-9 weeks of medication 1-after 8-9 weeks of medication 2

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints of this study are: to investigate the relationships between before mentioned medications and spirometry (MEF50) impulse oscillometry (IOS) (Ax) multiple breath nitrogen washout test (MBNW) (Sacin) fractional exhaled nitric oxide (FeNO) results (NOalv) impedance pneumography the amount of symptom free days need of bronchodilator points of AsthmaControlTest electrical diary results (KAMUHealth®) microspirometry ;Timepoint(s) of evaluation of this end point: Baseline-after 8-9 weeks of medication 1-after 8-9 weeks of medication 2	—

Measure

Time frame

Secondary end point(s): Secondary endpoints of this study are: to investigate the relationships between before mentioned medications and spirometry (MEF50) impulse oscillometry (IOS) (Ax) multiple breath nitrogen washout test (MBNW) (Sacin) fractional exhaled nitric oxide (FeNO) results (NOalv) impedance pneumography the amount of symptom free days need of bronchodilator points of AsthmaControlTest electrical diary results (KAMUHealth®) microspirometry ;Timepoint(s) of evaluation of this end point: Baseline-after 8-9 weeks of medication 1-after 8-9 weeks of medication 2

—

Countries

Finland

Contacts

Public ContactPrincipal Investigator Mika Mäkelä

HUS / Mika Mäkelä

mika.makela@hus.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026