A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of devices of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma

A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of devices of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma - Study on the efficacy of a fixed-dose combination of fluticasone propionate and formoterol fumarate hydrate (Flutiform)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012327

Enrollment

Registered

2018-11-18

Start date

2013-11-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Bronchial asthma

Interventions

Patients will be randomly assigned to either Flutiform 50 Aerosol (2 inhalations, 2 times/day) or Adoair Diskus 100 (1 inhalation, 2 times/day) in a 1:1 allocation. The patients assigned to Flutiform

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Outpatients (2) Patients in Step 2 or higher in treatment described in Asthma Prevention and Management Guideline 2012 (3) Patients with inadequately or poorly controlled asthma with existing therapies (see Asthma Prevention and Management Guideline 2012) (4) Patients who can use inhalation device properly and have been receiving low doses or more of ICS or ICS/LABA combination drug or taking LABA more than a low dose ICS 4 weeks or longer prior to study registration (5) Patients who have reversible airflow limitation for 12 months before study initiation (15% or greater improvement of FEV1.0, 15-30 minutes after inhalation of SABA) (6) Patients who voluntary provide written informed consent form after having been fully informed about and understand the requirements of study participation

Exclusion criteria

Exclusion criteria: (1) Patients who have experienced adverse drug reactions caused by treatment with an ICS, LABA, or concomitant use or a combination of ICS and LABA (2) Patients with severe cardiac, hepatic, renal, pulmonary, or hematologic disease (3) Patients with complications of apparent chronic obstructive pulmonary disease (COPD) (4) Patients with complications of malignant tumors (5) Patients with a history of smoking within the past 1 year (6) Patients who are pregnant, lactating, or desire to conceive during the study period (7) Patients who were judged unsuitable for enrollment in the study by the investigator or the sub-investigator

Design outcomes

Primary

Measure	Time frame
Comparison of FEV1 at week 2	—

Secondary

Measure	Time frame
- ACQ - FEV1%, %FEV1, FEV1 - PEF - Number of days when therapeutic drugs for asthma attacks are used, number of days when asthma symptoms are present, and asthma symptom score - Questionnaire scores on inhaler (device maneuverability)	—

Countries

Japan

Contacts

Public ContactHiroshi Yabe

Bell Medical Solutions Inc Clinical Research Group, Clinical Research and Development Division

jimukyoku@medical-bs24.com0120-313-626

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026