UMIN-CTR Clinical Trial

Public title

Study of the effect of the exhale through the nose method by Inhaled corticosteroid and Long Acting Beta2 Agonist (ICS / LABA) combination drug in patients with asthma merger sinusitis

Acronym

Study of the effect of the exhale through the nose method by ICS / LABA combination drug in patients with asthma merger sinusitis

Scientific Title

Study of the effect of the exhale through the nose method by Inhaled corticosteroid and Long Acting Beta2 Agonist (ICS / LABA) combination drug in patients with asthma merger sinusitis

Scientific Title:Acronym

Study of the effect of the exhale through the nose method by ICS / LABA combination drug in patients with asthma merger sinusitis

Region

Japan

Condition

Asthma
Sinusitis
Eosinophilic sinusitis

Classification by specialty

Pneumology

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In patients asthma merger sinusitis, to examine the efficacy and safety of the Inhaled by exhale through the nose method Inhaled corticosteroid and Long Acting Beta2 Agonist combination drug

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Evaluation of the Lund-Mackey staging system CT scoring three months after the intervention

Key secondary outcomes

Rhinosinusitis endoscopic findings, eosinophils in nasal discharge, respiratory function tests, FeNO, IL-4, IL-5, IL-10, INF-gamma, ECP, peripheral blood eosinophil count, non-specific IgE quantitation, SNOT-22 (Sino-Nasal Outcome Test-22), ACT (Asthma Control Test)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

exhale through the nose method Fluticasone propionate / formoterol fumarate combination(:FFC) drug
Inhaled by exhale through the nose method twice a day 2 times per once.
Between three months.

Interventions/Control_2

Inhalation Fluticasone propionate / formoterol fumarate combination(:FFC) drug
Inhaled twice a day 2 times per once.
Between three months.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

There are nasal symptoms in a person who has been diagnosed with asthma by a respiratory physician, who the existence of sinusitis in the paranasal sinuses CT has been confirmed.
Who can stop using a combination banned drug during a given period and test period of the previous inspection.

Key exclusion criteria

1)Those who in this study implementation period is scheduled to surgery for sinusitis
2)A person who has a history that is considered to have an impact on the evaluation of the study (drug abuse, dependence, alcohol abuse, dependence, digestive, heart, liver, lung, eye, blood diseases, etc.)
3)person of corticosteroids, while taking cromolyn sodium (oral oral medicine, nasal drops is not allowed)
4)those who are taking anti-histamines
5)Those who are receiving immunotherapy, including desensitization therapy
6)pregnant women, breast-feeding women
7)current smokers, non smoking duration a person of less than one year
8)Those who can not properly enforce the respiratory function test
9)Other, who is determined to be ineligible as a subject of the present study than test doctor

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	HIRANO KOJIRO

Organization

Showa University Koto Toyosu Hospital

Division name

Department of Otorhinolaryngology

Zip code

Address

5-1-38, Toyosu, Koto-ku, Tokyo, 135-8577, Japan

TEL

03-6204-6000

Email

hirano.yasu@hotmail.co.jp

Name of contact person

1st name
Middle name
Last name	HIRANO KOJIRO

Organization

Showa University Koto Toyosu Hospital

Division name

Department of Otorhinolaryngology

Zip code

Address

5-1-38, Toyosu, Koto-ku, Tokyo, 135-8577, Japan

TEL

03-6204-6000

Homepage URL

Email

hirano.yasu@hotmail.co.jp

Institute

Department of Otorhinolaryngology Showa University Koto Toyosu Hospital

Institute

Department

Personal name

Organization

Department of Otorhinolaryngology Showa University Koto Toyosu Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

昭和大学江東豊洲病院(東京都)

Date of disclosure of the study information

2016

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

05

Month

10

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

07

Day

Last modified on

2018

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025109