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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002629
Receipt No. 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

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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
Email

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
Email htakahashi@tmghig.jp

Sponsor
Institute Tokyo Metropolitan Geriatric Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003181

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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