UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002629 |
|---|---|
| Receipt number | R000003181 |
| Scientific Title | Association of efficacy of long acting beta 2-agonist (LABA) and single nucleotide polymorphisms (SNP) of beta 2-adrenergic receptors in elderly patients with COPD |
| Date of disclosure of the study information | 2009/10/15 |
| Last modified on | 2009/10/14 19:57:22 |
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Basic information
Public title
Association of efficacy of long acting beta 2-agonist (LABA) and single nucleotide polymorphisms (SNP) of beta 2-adrenergic receptors in elderly patients with COPD
Acronym
Efficacy of LABA and SNP of beta 2-adrenergic receptors
Scientific Title
Association of efficacy of long acting beta 2-agonist (LABA) and single nucleotide polymorphisms (SNP) of beta 2-adrenergic receptors in elderly patients with COPD
Scientific Title:Acronym
Efficacy of LABA and SNP of beta 2-adrenergic receptors
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate an appropriate selection of LABA in elderly patients with COPD, we study the relationship between efficacy of LABA (tulobuterol patch and inhaled salmeterol therapy) and single nucleotide polymorphisms (SNP) of beta 2-adrenergic receptors in elderly patients with stable COPD by a randomized crossover study.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes were relationship between change in sprirometric values and 6-minute walk distance (6MWD) and SNP of beta 2-adrenergic receptors in each medication (tulobuterol patch and inhaled salmeterol therapy). The secondary outcomes were quality of life (QOL) measured by St.George's Respiratory Questionnaire.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We conducted a randomized, crossover study comparing the efficacy of LABA between transdermal tulobuterol patch (TP, 2 mg once a day) and inhaled salmeterol (50microgram, twice a day) in elderly COPD patients. Beta 2-adrenergic receptor (beta2AR) genotypes at beta 2-AR -16 and -27 were determined by a restriction fragment length polymorphism assay after amplification of a polymerase chain reaction (PCR) product in each patient.
Interventions/Control_2
We conducted a randomized, crossover study comparing the efficacy of LABA between transdermal tulobuterol patch (TP, 2 mg once a day) and inhaled salmeterol (50microgram, twice a day) in elderly COPD patients. Beta 2-adrenergic receptor (beta2AR) genotypes at beta 2-AR -16 and -27 were determined by a restriction fragment length polymorphism assay after amplification of a polymerase chain reaction (PCR) product in each patient.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients had clinical features consistent with the presence of moderate-to-severe COPD including spirometric criteria of post-bronchodilator FEV1/FVC ratio of less than 0.7 and FEV1 between 30% and 80% of the predicted values for height and age, and kept stable conditions during the past month.
Key exclusion criteria
Exclusion criteria included age younger than 65, dementia and any previously usage of inhaled medications such as beta 2-agonists, anti-cholinergics or corticosteroids, patched beta 2--agonist, or systemic corticosteroids. Patients with dermatological disorders, severe heart diseases, uncontrolled hypertension or other diseases for whom patch preparations or treatments with beta 2-agonists was considered inappropriate were also excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Takahashi |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015
TEL
03-3964-1141
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Takahashi |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015
TEL
03-3964-1141
Homepage URL
htakahashi@tmghig.jp
Sponsor or person
Institute
Tokyo Metropolitan Geriatric Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Geriatric Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 10 | Month | 15 | 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
| 2009 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 14 | Day |
Last modified on
| 2009 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003181
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| Registered date | File name |
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| Registered date | File name |
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