UMIN-CTR Clinical Trial

Public title

The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).

Acronym

The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis.

Scientific Title

The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis in an artificial exposure chamber(OHIO Chamber).

Scientific Title:Acronym

The effect of combination therapy of fluticasone furoate nasal spray with levocetirizine hydrochloride in patients with Japanese cedar pollinosis.

Region

Japan

Condition

Japanese cedar pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify effect of combination therapy of fluticasone furoate with levocetirizine hydrochloride on nasal symptoms of Japanese cedar pollen exposure in an artificial exposure chamber(OHIO Chamber).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cumulative incidence rate of nasal symptoms after 3hr-pollen exposure

Key secondary outcomes

Nasal symptoms
Ocular symptoms
Oral-pharyngeal symptoms
Amount of nasal discharge
Number of sneezing

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Subject takes levocetirizine hydrochloride 5mg and fluticasone furoate nasal spray 110 micro g. once a day at previous night of pollen exposure.

Interventions/Control_2

Subject takes levocetirizine hydrochloride 5mg and fluticasone furoate nasal spray placebo once a day at previous night of pollen exposure.

Interventions/Control_3

Subject takes levocetirizine hydrochloride placebo and fluticasone furoate nasal spray placebo once a day at previous night of pollen exposure.

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

1) CAP-RAST score against Japanese cedar pollen over class 2 within the last 2 years.
2) Patients who have typical seasonal allergic rhinitis symptoms for at least 2 years. The presence of moderate and more symptoms, subject with main symptom of nasal congestion.
3) Written informed consent is required.

Key exclusion criteria

1) A hisotry of nasal and/or ocular disease
2) Evidence of upper and/or lower respiratory tract inflammation within 2 weeks prior to IC
3) An episode of sinusitis within 30 days prior to IC
4) A hisotry of treatment with steroid injection within 6 months prior to IC
5) A hisotry of treatment with steroid (oral and topical) within 4 weeks prior to IC
6) A history of asthma (include of child asthma)
7) A history of anaphylaxis
8) Patients who have the hypersensitivity to study drugs
9) Patients with desensitization therapy
10) Patients with nasal anatomical deformities leading to obstruction within 1 year prior to IC
11) Patients with cardiac, renal disease, or hepatic insufficiency
12) Pregnancy, breast-feeding woman, potencial pregnancy, patient who wish to become pregnant during this study
13) Patients who were judged to be unsuitable for patient enrollment by the doctor

Target sample size

42

Name of lead principal investigator

1st name
Middle name
Last name	Kimihiro Okubo

Organization

Nippon Medical School

Division name

Department of Otorhinolaryngology and Head /Neck Surgery

Zip code

Address

1-1-5 Sendagi, Bunkyo-ku Tokyo 113-8603, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Kiyochika Suematsu

Organization

Medical Corporation Shinanokai, Samoncho Clinic

Division name

Pharmaceutical Dept.,

Zip code

Address

Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo, 160-0017, Japan

TEL

03-5366-3641

Homepage URL

Email

ki-suematsu@samoncho-clinic.jp

Institute

Nippon Medical School

Institute

Department

Personal name

Organization

The incorporated non-profit organization
Clinical Research Support Center Kyusyu

Organization

Division

Category of Funding Organization

Non profit foundation

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

医療法人社団信濃会 左門町クリニック

Date of disclosure of the study information

2011

Year

10

Month

07

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

2011

Year

09

Month

26

Day

Date of IRB

Anticipated trial start date

2011

Year

10

Month

01

Day

Last follow-up date

2011

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

10

Month

07

Day

Last modified on

2012

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007708