UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025040
Receipt number R000028816
Scientific Title A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis
Date of disclosure of the study information 2017/01/01
Last modified on 2016/11/29 11:09:42

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Basic information

Public title

A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis

Acronym

Clinical efficacy of different type of inhaler devices for asthmatics with ECRS

Scientific Title

A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis

Scientific Title:Acronym

Clinical efficacy of different type of inhaler devices for asthmatics with ECRS

Region

Japan


Condition

Condition

asthma with eosinophilic chronic rhinosinusitis

Classification by specialty

Pneumology Clinical immunology Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic chronic rhinosinusitis treated with inhaled corticosteroid exhalation through the nose

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Levels of fractionated exhaled nitrogen oxide 8 weeks after starting each trial drug administration

Key secondary outcomes

Lung function, nasal polyp score and sinus CT score 8 weeks after starting each trial drug administration


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Adair Discus 500 microgram one inhalation twice daily for 8 weeks, followed by Relvar Ellipta 200 microgram one inhalation once daily for 8 weeks

Interventions/Control_2

Relvar Ellipta 200 microgram one inhalation once daily for 8 weeks, followed by Adair Discus 500 microgram one inhalation twice daily for 8 weeks

Interventions/Control_3


Interventions/Control_4


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. patients with good asthma control under more than 8 weeks treatment with Adair Aerosol 250 microgram 2 inhalation twice daily though the nose
2. non-smoker

Key exclusion criteria

1. exacerbation within 4 weeks (eg. infection and asthma attack)
2. concomitant disease currently treated (eg. heart diseases, hematologic disorders, respiratory diseases)
3. pregnant patients
4. possibility of lack of examination security.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Kobayashi

Organization

Kansai Medical University

Division name

Department of Otolaryngology, Neck and head surgery

Zip code


Address

2-5-1 Shinmachi, Hirakata, Osaka

TEL

072-804-0101

Email

kobayosh@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiki Kobayashi

Organization

Kansai Medical University

Division name

Department of Otolaryngology, Neck and head surgery

Zip code


Address

2-5-1 Shinmachi, Hirakata, Osaka

TEL

072-804-0101

Homepage URL


Email

kobayosh@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 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

Preinitiation

Date of protocol fixation

2016 Year 11 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 01 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

2016 Year 11 Month 29 Day

Last modified on

2016 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028816


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name