UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006291 |
|---|---|
| Receipt number | R000007449 |
| Scientific Title | Comparison of response to salmeterol/fluticasone combination (SFC) therapy in elderly- versus younger- onset asthma and COPD |
| Date of disclosure of the study information | 2011/09/15 |
| Last modified on | 2012/09/10 09:08:06 |
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Basic information
Public title
Comparison of response to salmeterol/fluticasone combination (SFC) therapy in elderly- versus younger- onset asthma and COPD
Acronym
Comparison of response to SFC in elderly- versus younger- onset asthma, and COPD
Scientific Title
Comparison of response to salmeterol/fluticasone combination (SFC) therapy in elderly- versus younger- onset asthma and COPD
Scientific Title:Acronym
Comparison of response to SFC in elderly- versus younger- onset asthma, and COPD
Region
| Japan |
Condition
Condition
Bronchial asthma, COPD
Classification by specialty
| Pneumology | Clinical immunology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
At the elderly-(over 65) and young- (under 40) onset patients with mild to moderate persistent asthma, and COPD, treated by SFC. To compare changes in clinical indicator (symptoms, airflow obstruction, airway inflammation).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Asthma control questionnaire (ACQ)
Spirometry
exhaled nitric oxide
exacerbation
Asthma Control Test (ACT)
COPD Assessment Test (CAT)
Key secondary outcomes
Relevance of changes in the primary
Outcomes.
The following background factors at start of intervention.
Age
Gender
Height
Weight
Duration of disease
Smoking history
Co morbidity
Blood test
Reversibility of airway.
Adverse events, serious adverse
events, side effects, number and frequency of serious side effects.
The percentage of discontinued patients(%)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Salmeterol/fluticasone propionate combination aerosol, 2 puff twice daily, for 12, 24 weeks in younger-onset asthma
Interventions/Control_2
Salmeterol/fluticasone propionate combination aerosol, 2 puff twice daily, for 12, 24 weeks in elderly-onset asthma
Interventions/Control_3
Salmeterol/fluticasone propionate combination aerosol, 2 puff twice daily, for 12, 24 weeks in COPD
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Asthma:
1, At entry, patients with adult asthma developed within three years.
Gender does not matter.
2, Adult patients with mild to moderate persistent asthma.
3, Patient developed in over 65 years registered as elderly-onset asthma.
4, Patient developed in 40 years or less registered as young-onset asthma.
COPD:
1, Diagnosed with COPD, and unused inhaled corticosteroid. Gender does not matter.
2, Long term treatment with bronchodilator including long acting beta-agonist.
Common criteria:
Patient was able to get a written consent from the person.
Key exclusion criteria
Asthma:
History of smoking.
COPD:
Current smokers.
Common criteria:
1, Diagnosed with non-COPD / non-asthma respiratory disorders and heart diseases.
2, Poor adherence.
3, Use inhaled, oral, and injection steroids within 8 weeks before enrollment.
4, Patients have hypersensitivity to salmeterol or fluticasone propionate, or suspected patient.
5, The patients who are inappropriate considered by physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Ichinose |
Organization
Wakayama Medical university
Division name
Third Department of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuto Matsunaga |
Organization
Wakayama Medical university
Division name
Third Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
kazmatsu@wakayama-med.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Wakayama Medical university
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The results was reported as an original article.
Am J Geriatric Soc 2012;60:1587-1588
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
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 06 | Day |
Last modified on
| 2012 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007449
