UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001503 |
|---|---|
| Receipt number | R000001816 |
| Scientific Title | Comparison of adherence and efficacy between inhaled salmeterol and transdermal tulobuterol patch in elderly COPD patients |
| Date of disclosure of the study information | 2008/11/13 |
| Last modified on | 2008/11/12 20:29:37 |
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Basic information
Public title
Comparison of adherence and efficacy between inhaled salmeterol and transdermal tulobuterol patch in elderly COPD patients
Acronym
Comparison of adherence and efficacy between inhaled salmeterol and transdermal tulobuterol patch
Scientific Title
Comparison of adherence and efficacy between inhaled salmeterol and transdermal tulobuterol patch in elderly COPD patients
Scientific Title:Acronym
Comparison of adherence and efficacy between inhaled salmeterol and transdermal tulobuterol patch
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inhaled long acting 2-agonists (LABA) are often poorly adhered to by elderly patients with chronic obstructive pulmonary disease (COPD). The objectives of this study were to compare drug-specific compliance of transdermal and inhaled LABA, and to identify the risk factors for underuse of inhaled LABA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcomes were adherence to the medication and change in a 6-minute walk distance (6MWD).
Key secondary outcomes
The secondary outcomes were spirometric values and quality of life (QOL) measured by the St.George's Respiratory Questionnaire.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
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 adherence to and efficacy of LABA between the transdermal tulobuterol patch (TP, 2 mg once a day) and inhaled salmeterol (50 g, twice a day) in elderly COPD patients.
Interventions/Control_2
We conducted a randomized, crossover study comparing the adherence to and efficacy of LABA between the transdermal tulobuterol patch (TP, 2 mg once a day) and inhaled salmeterol (50 g, twice a day) in elderly COPD patients.
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 the 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 their condition remained stable during the past month.
Key exclusion criteria
The exclusion criteria included age younger than 65 years, dementia and any previously use of inhaled medications such as 2-agonists, anti-cholinergics or corticosteroids, patched 2-agonist, or systemic corticosteroids. Patients with dermatological disorders, severe heart diseases, uncontrolled hypertension or other diseases for which patch preparations or treatments with 2-agonists was considered inappropriate were also excluded.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Takahashi |
Organization
The 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
The Tokyo Metropolitan Geriatric Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo 173-0015
TEL
03-3964-1141t
Homepage URL
Sponsor or person
Institute
The Tokyo Metropolitan Geriatric Hospital
Institute
Department
Personal name
Funding Source
Organization
The Tokyo Metropolitan Geriatric Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2008 | Year | 11 | Month | 13 | 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
Twenty-six patients with moderate-to-severe COPD were enrolled. Overall compliance rate was 87.7+2.6 % for TP and 72.2+4.9 % for salmeterol (p<0.05). Adherence to TP was greater than that to salmeterol in patients >80 years old (y/o) and those with mini-mental state examination (MMSE) score <25 (p<0.05 and p=0.06, respectively), but not in patients<80 y/o or those with MMSE>25. As compared with baseline, a similar degree of increase in 6MWD, %VC, %FVC, FEV1 and FEF25-75% was demonstrated after treatment with TP and salmeterol (p<0.05), though QOL was not significantly improved. Adherence to TP and salmeterol was positively correlated with increases in 6MWD.
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
| 2006 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 12 | Day |
Last modified on
| 2008 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001816
