Last updated: 11/03/2018 19:15:54
Community based patient questionnaire survey to assess asthma control in 4 Indian cities
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Community based patient questionnaire survey to assess asthma control in 4 Indian cities
Trial description: According to the Global Initiative for Asthma (GINA) guidelines, the main goal of asthma treatment is to achieve and maintain clinical control. The Asthma Control Test (ACT) is a simple and validated tool to measure asthma control. A sub-analysis of data from Indian patients (from Mumbai, Delhi, Kolkata, Bengaluru) in Asthma Insights and Reality in Asia-Pacific (AIRIAP) 2006 survey, showed that 70% adults and 48% children had ‘not well-controlled asthma’ as indicated by an ACT score of 5-19. Over the last 6 years it appears that access to diagnostic tests, monitoring tools and better treatment options for asthma has increased in India. Therefore we expect that asthma control has improved in the last 6 years.This is a community based cross-sectional questionnaire survey of 550 asthma patients (ages 4 to 50 years) across 4 Indian cities, viz Mumbai, Delhi, Bengaluru and Kolkata. The aim of this survey will be to assess the current level of asthma control based upon the ACT score, the usage of diagnostic and monitoring tools for asthma, the usage of different classes of asthma medication, the level of healthcare utilization, the level of work productivity and activity impairment (WPAI), the relation between ACT score and WPAI outcomes, between ACT score and different classes of asthma medication, between ACT score and adherence to asthma medication. This survey will be conducted by Ipsos Healthcare using cluster sampling methodology.The results of this survey will help us to understand the extent to which these Indian cities have met GINA defined goals for asthma control (well controlled, total control) and to identify and focus on those areas that need additional resource to achieve guideline defined asthma control.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of all patients with ‘controlled’ asthma (ACT score > 19)
Timeframe: Survey over 3 months
Proportion of all patients with not well controlled asthma
Timeframe: Survey over 3 months
Secondary outcomes:
Proportion of patients with 'not well controlled asthma'
Timeframe: Survey over 3 months
Proportion of patients with 'well controlled asthma'
Timeframe: Survey over 3 months
Proportion of children
Timeframe: Survey over 3 months
Usage of different classes of medication
Timeframe: Survey over 3 months
Association between ACT and WPAI
Timeframe: Survey over 3 months
Usage of healthcare
Timeframe: Survey over 3 months
Usage of spirometry
Timeframe: Survey over 3 months
ACT score by adherence to therapy
Timeframe: Survey over 3 months
Work Productivity and Activity Impairment (WPAI)
Timeframe: Survey over 3 months
Usage of peak flow monitoring
Timeframe: Survey over 3 months
ACT score by class of medication
Timeframe: Survey over 3 months
Proportion of patients with 'total controlled asthma'
Timeframe: Survey over 3 months
Interventions:
Enrollment:
550
Primary completion date:
Not applicable
Observational study model:
Ecologic Or Community
Time perspective:
Cross-sectional
Clinical publications:
Not applicable
- Physician diagnosed asthma together with either current use of asthma medication or the occurrence of asthma attacks and symptoms during the previous year
- Individuals with a Smoking Index more than 100 will be excluded from this survey.
Inclusion and exclusion criteria
Inclusion criteria:
- Physician diagnosed asthma together with either current use of asthma medication or the occurrence of asthma attacks and symptoms during the previous year
Exclusion criteria:
- Individuals with a Smoking Index more than 100 will be excluded from this survey.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
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
2012-27-11
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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