A prospective, randomized, open-label parallel-group clinical study to investigate effects of fluticasone/formoterol pMDI (Flutiform) vs fluticasone/salmeterol DPI (Adoair Diskus) in asthmatic patients with small airway inflammation

A prospective, randomized, open-label parallel-group clinical study to investigate effects of fluticasone/formoterol pMDI (Flutiform) vs fluticasone/salmeterol DPI (Adoair Diskus) in asthmatic patients with small airway inflammation - The effects of fluticasone/formoterol (Flutiform) in asthmatic patients with small airway inflammation, compared with fluticasone/salmeterol (Adoair Diskus)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012331

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 3 in treatment described in Asthma Prevention and Management Guideline 2012 (3) Patients with well-controlled asthma indicated by an Asthma Control Test (ACT) score 20 or greater (4) Patients who can use Diskus properly and have been receiving Adoair Diskus 4 weeks or longer prior to study enrollment (5) FeNO 30 ppb or greater (6) Patients thought to have small airway inflammation indicated by MostGraph parameters which represent small airway resistance (7) 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 ECP in late-phase induced sputum at week 8	—

Secondary

Measure	Time frame
- ECP and SP-D in induced sputum - FeNO - R5, R20, R5-R20, X5, AX measured by MostGraph - FEV1, %FEV1, FEV1%, V25, V50 - ACQ	—

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