Last updated: 11/07/2018 12:17:29
Patient Satisfaction and Symptom Management Goal: Survey of Japanese adult patients with bronchial asthma receiving inhaled corticosteroid-containing medications
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Patient Satisfaction and Symptom Management Goal: Survey of Japanese adult patients with bronchial asthma receiving inhaled corticosteroid-containing medications
Trial description: This study is a multicentered, non-drug interventional, prospective study. This study aims to provide some information regarding influencing factors to overestimation of level of asthma control in order to support health care professionals to raise patient expectations of asthma management. It may also help them in developing a personalized approach to asthma care. The primary objective of this study is to assess patient satisfaction with asthma care before and after being shown the asthma symptom management goals outlined in Japanese Asthma Prevention and Management Guideline (JGL) 2012. The secondary objective is to explore factors influencing satisfaction level change.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Changes in satisfaction level with asthma care before and after being shown the asthma symptom management goals outlined in Japanese Asthma Prevention and Management Guideline 2012
Timeframe: the time of study assessment visit
Secondary outcomes:
Extent of influence of patient factors on primary endpoint
Timeframe: the time of study assessment visit
Interventions:
Not applicable
Enrollment:
520
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Cross-sectional
Clinical publications:
Yasuhiro Gon, Jun Takai, Isao Mukai, Takako Hattori, Akihiro Kobayashi. Relationship between Patient Satisfaction and Symptom Management Goal: Survey of Japanese adult patients with bronchial asthma receiving inhaled corticosteroid-containing medications. Ther Res. 2016;37(7):683-94.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
September 2014 to January 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
none
- Japanese men and women
- aged ≥20 years at the time of enrollment
- received regular treatment with systemic steroid within 8 weeks
- received anti-IgE antibody treatment within 8 weeks
Inclusion and exclusion criteria
Inclusion criteria:
- Japanese men and women
- aged ≥20 years at the time of enrollment
- with diagnosis of bronchial asthma
- received ICS or ICS/LABA at least 4 weeks as controller
- capable of giving written informed consent
Exclusion criteria:
- received regular treatment with systemic steroid within 8 weeks
- received anti-IgE antibody treatment within 8 weeks
- with LRTI and/or URTI at the time of study assessment visit
- judged by the investigators/sub-investigators as with exacerbation at the time of study assessment visit
- had enrolled in any clinical trial within 3 months or who are treating in clinical trial
- judged by the investigators/sub-investigators as having difficulty joining this survery (subjects with dementia, rheumatism and other disability)
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
2015-31-01
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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