UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012332
Receipt number R000014419
Scientific Title A prospective, randomized, open-label parallel-group clinical study to investigate effects of fluticasone/formoterol pMDI (Flutiform) vs fluticasone/salmeterol DPI (Adoair Diskus) or pMDI (Adoair Aerosol) in asthmatic patients with small airway inflammation
Date of disclosure of the study information 2018/11/18
Last modified on 2014/11/21 18:15:44

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Basic information

Public title

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

Acronym

The effects of fluticasone/formoterol (Flutiform) in asthmatic patients with small airway inflammation, compared with fluticasone/salmeterol DPI (Adoair Diskus) or pMDI (Adoair Aerosol)

Scientific Title

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

Scientific Title:Acronym

The effects of fluticasone/formoterol (Flutiform) in asthmatic patients with small airway inflammation, compared with fluticasone/salmeterol DPI (Adoair Diskus) or pMDI (Adoair Aerosol)

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of fluticasone/formoterol pMDI (Flutiform) in patients with small airway inflammation, compared with fluticasone/salmeterol DPI (Adoair Diskus) or pMDI (Adoair Aerosol), which asthma was well controlled by long-term asthma management using fluticasone/salmeterol DPI (Adoair Diskus).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison of R5-R20 at week 4 measured by IOS

Key secondary outcomes

- R5, R20, R5-R20, X5, and Ax measured by IOS
- FeNO
- FEV1, %FEV1, FEV1%, V25, and V50
- ACQ


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Step 1: 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 50 Aerosol will be treated with the drug for 4 weeks.

Interventions/Control_2

Step 1: 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 Adoair Diskus 100 will be and treated with the drug for 4 weeks.

Interventions/Control_3

Step 2: Patients will be randomly assigned to either Flutiform 50 Aerosol (2 inhalations, 2 times/day) or Adoair 50 Aerosol (2 inhalations, 2 times/day) in a 1:1 allocation. The patients assigned to Flutiform 50 Aerosol will be treated with the drug for 4 weeks.

Interventions/Control_4

Step 2: Patients will be randomly assigned to either Flutiform 50 Aerosol (2 inhalations, 2 times/day) or Adoair 50 Aerosol (2 inhalations, 2 times/day) in a 1:1 allocation. The patients assigned to Flutiform 50 Aerosol will be treated with the drug for 4 weeks.

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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 by existing therapies (see Asthma Prevention and Management Guideline 2012)
(4) Patients who can use Diskus properly and have been receiving Adoair Diskus 4 weeks or longer prior to study enrollment
(5) IOS parameters of R5-R20 0.05 kPa/L/s or greater
(6) FeNO 35 ppb or greater
(7) Patients who voluntary provide written informed consent form after having been fully informed about and understand the requirements of study participation

Key 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

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Soichiro Hozawa

Organization

Hiroshima Allergy and Respiratory Clinic

Division name

Medical director

Zip code


Address

Daiichi Teraoka building 6F, 1-9-28, Hikari-machi, Higashi-ku, Hiroshima

TEL

082-568-1167

Email

jimukyoku@medical-bs24.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Yabe

Organization

Bell Medical Solutions Inc

Division name

Clinical Research Group, Clinical Research and Development Division

Zip code


Address

Tokyu Bldg. East No. 3, 2-16-8, Minami Ikebukuro, Toshima-ku, Tokyo

TEL

0120-313-626

Homepage URL


Email

jimukyoku@medical-bs24.com


Sponsor or person

Institute

KYORIN Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

KYORIN Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

広島アレルギー呼吸器クリニック(広島県)


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 09 Month 24 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 18 Day

Last modified on

2014 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014419


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name