UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001644 |
|---|---|
| Receipt number | R000001976 |
| Scientific Title | A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis |
| Date of disclosure of the study information | 2009/01/17 |
| Last modified on | 2016/02/29 23:59:50 |
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Basic information
Public title
A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis
Acronym
Mometasone furoate hydrate nasal spray for pollinosis: regular versus as-needed use
Scientific Title
A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis
Scientific Title:Acronym
Mometasone furoate hydrate nasal spray for pollinosis: regular versus as-needed use
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of regular and as-needed use of Mometasone furoate hydrate nasal spray for Japanese cedar pollinosis with the disease specific quality of life questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Overall quality of life score of Rhinoconjunctivitis Quality of Life Questionnire.
Key secondary outcomes
1) Each score of seven domains of RQLQ.
2) Two summary scores (PCS and MCS) of SF-36 v2.
3) Each severity score of four daily nasal symptoms (runny nose, itchy nose , stuffy nose, and sneezing).
4) Total nasal symptom score (the sum of four nasal symptom scores).
5) Each severity score of three daily ocular symptoms (eye itchiness, eye redness, and tearing).
6) Total ocular symptom score (the sum of three ocular symptom scores).
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 considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Regular use group: Taking two puffs of Mometasone furoate hydrate nasal spray into each nostril (total 200 ug/day) every morning from the onset of nasal symptoms.
Interventions/Control_2
As-needed use group: Taking two puffs of Mometasone furoate hydrate nasal spray into each nostril once a day (total 200 ug/day) in case of the patient having troublesome nasal symptoms.
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
| 16 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) A history of Japanese cedar pollinosis for at least one season before study entry.
2) Positive allergy skin test to Japanese cedar pollen or Japanese cedar pollen specific IgE RAST score >= class 2.
3) Written informed consent is required.
Key exclusion criteria
1) Taking any immunosuppressive drugs or systemic steroid drugs within six months before study entry.
2) Taking any antibiotics within two weeks before study entry.
3) Taking any anti-allergy drugs within two weeks before study entry.
4) Using any anti-allergy nasal drops within two weeks before study entry.
5) Under treatment of buildup phase of specific immunotherapy.
6) Patients with deflected nasal septum, sinusitis, or nasal polyps which cause a barrier to evaluate nasal symptoms.
7) Patients with upper respiratory inflammation, respiratory infection, or severe bronchial asthma.
8) Patients with severe cardiac, hepatic, kidney, or hematological disease.
9) A history of hypersensitivity to mometasone furoate hydrate, loratadine, or sodium cromoglycate.
10) Pregnant or lactating women and women who may be pregnant.
11) Taking a drug of erythromycin or cimetidine.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Masuyama |
Organization
University of Yamanashi
Division name
Department of Otorhinolaryngology, Head & Neck Surgery
Zip code
Address
1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN
TEL
055-273-6769
mkeisuke@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goro Takahashi |
Organization
University of Yamanashi
Division name
Department of Otorhinolaryngology, Head & Neck Surgery
Zip code
Address
1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN
TEL
055-273-6769
Homepage URL
http://www.yuent.umin.jp/kafun/
tgoro@yamanashi.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 01 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 17 | Day |
Last modified on
| 2016 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001976
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