Last updated: 11/07/2018 11:37:26
Study of barriers to adherence using the Adherence Starts with Knowledge 20 (ASK-20) in adult asthma patients receiving treatment with inhaled corticosteroid-containing drug products
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study of barriers to adherence using the Adherence Starts with Knowledge 20 (ASK-20) in adult asthma patients receiving treatment with inhaled corticosteroid-containing drug products
Trial description: The aim of this study is to investigate the barriers to medication adherence using the Adherence Starts with Knowledge 20 (ASK-20) questionnaire in adult Japanese asthma patients who have received treatment with inhaled corticosteroid (ICS)-containing drug products for at least 2 years. In addition, the correlation of the ASK-20 total score with prescription rates of ICS-containing drug products (rate of actual amount prescribed versus theoretical amount of drug needed) will also be investigated.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean ASK-20 score for each barrier
Timeframe: visit1
Secondary outcomes:
Prescription rate of ICS-containing drug products
Timeframe: visit1
Barrier count based on ASK-20
Timeframe: visit1
ASK-20 total score
Timeframe: visit1
Questionnaires
Timeframe: visit1
Asthma Control Test
Timeframe: visit1
Interventions:
Not applicable
Enrollment:
300
Primary completion date:
Not applicable
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Ryo Atsuta, Yasuo To, Susumu Sakamoto, Isao Mukai, Akihiro Kobayashi, Arisa Kinoshita, Kazuhisa Takahashi. Assessing barriers to medication adherence using the Adherence Starts with Knowledge 20 questionnaire for Japanese adult patients with bronchial asthma receiving inhaled corticosteroid-containing medications. Ther Res.2015;36(4):341-353
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
April 2013 to August 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
none
- Japanese men and women
- Age 20 years or older at the time of enrollment
- Patients who have received treatment with beta 2 concomitant ICSs or ICS/LABAs
- Patients judged by the investigator/sub-investigator as unsuitable for the study
Inclusion and exclusion criteria
Inclusion criteria:
- Japanese men and women
- Age 20 years or older at the time of enrollment
- Patients who have received treatment with ICS or ICS/LABA at a fixed dose for at least 2 years
- Patients who have not visited other hospitals for treatment of bronchial asthma
- Patients judged by the investigators/sub-investigators as able to comply with the study protocol
- Patients who are capable of giving written informed consent
Exclusion criteria:
- Patients who have received treatment with beta 2 concomitant ICSs or ICS/LABAs
- Patients judged by the investigator/sub-investigator as unsuitable for the study
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2013-09-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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Access to clinical trial data by researchers
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