Last updated: 11/03/2018 19:15:54

Community based patient questionnaire survey to assess asthma control in 4 Indian cities

GSK study ID
116516
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Other: Not applicable
  • Enrollment:
    550
    Primary completion date:
    Not applicable
    Observational study model:
    Ecologic Or Community
    Time perspective:
    Cross-sectional
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    July 2012 to November 2012
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    4 - 50 Year
    Accepts healthy volunteers
    none
    • 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.

    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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