Last updated: 01/31/2025 15:30:08

A study to determine prescribed treatment duration in participants with allergic rhinitis (AR)

GSK study ID
217857
See study documents
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: Allergic Rhinitis: Assessing Hindrances Encountered while Adhering to the recommended treatment Duration - physician and patient perspective
Trial description: This study will be conducted to analyze real world understanding of prescribed treatment duration of Intranasal Corticosteroids (INCS) from physician and participant’s perspective.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Average duration of physician reported prescribed INCS in participants with AR through patient record form (PRF)

Timeframe: Up to 3 months

Secondary outcomes:

Number of physicians with reasons for recommending INCS use in AR participants through physician survey and PRF

Timeframe: Up to 3 months

Number of factors influencing duration of INCS prescribed by physician in AR participants through physician survey and PRF

Timeframe: Up to 3 months

Number of physicians reporting next course of action of treatment based on participants INCS response through physician survey

Timeframe: Up to 3 months

Number of physicians with reasons for participant’s non adherence to prescribed treatment duration through physician survey and PRF

Timeframe: Up to 3 months

Average duration of physician reported prescribed INCS in participants with AR through participant survey

Timeframe: Up to 3 months

Average duration of self reported INCS use through participant survey

Timeframe: Up to 3 months

Number of participants with reasons for non adherence to prescribed treatment duration through participant survey

Timeframe: Up to 3 months

Interventions:
Not applicable
Enrollment:
1050
Primary completion date:
2023-28-04
Observational study model:
Cohort
Time perspective:
Cross-Sectional
Clinical publications:
Larenas-Linnemann DES, Domthong P, Di Francesco RC, González-Pérez R, Verma M. General practitioner and patient perspectives on intranasal corticosteroids for allergic rhinitis: Treatment duration and obstacles to adherence, findings from a recent survey. World Allergy Organ J. 2024 Jun 25;17(7):100925. PMCID: PMC11259959. PMID: 39035787 DOI: 10.1016/j.waojou.2024.100925
Medical condition
Rhinitis, Allergic
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
December 2022 to April 2023
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
No
  • Inclusion criteria for Physicians:
  • They should be practising as General Physician
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion criteria for Physicians:
  • They should be practising as General Physician
  • They should have between 3 to 35 years of practice experience
  • They should spend at least 60 percent (%) of their time in direct participant care.
  • They should have personally seen, and managed participants diagnosed with Allergic Rhinitis in the last 3 years
  • They should regularly prescribe INCS to participants diagnosed with Allergic Rhinitis
  • They have managed at least 5 participants per month of Allergic Rhinitis on average in the last 12 months
  • They can fill out three AR participant record forms
  • They can give informed consent Inclusion criteria for Participants:
  • Is male or female, age between 18 to 65 years (both inclusive) at time of informed consent
  • Diagnosed with Allergic Rhinitis
  • Has visited General Physicians for AR treatment
  • Has been initiated on INCS medication at least 12 months ago to treat Allergic rhinitis
  • Can give informed consent Exclusion Criteria for Physicians:
  • They have not treated more than 5 AR participants/month on average in the last 12 months
  • Reports any reasons they cannot complete the study Exclusion Criteria for Participants:
  • They are below 18 years or more than 65 years old (adults aged 65 years and more have a higher probability of comorbidities which may significantly impact treatment decisions for AR management and hence these participants have been excluded)
  • They are pregnant or lactating or planning to become pregnant (disease course of AR gets altered during pregnancy/lactation and management of AR may differ. Hence these participants have been excluded from the study
  • Reports any reasons they cannot complete the study

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2023-28-04
Actual study completion date
2023-28-04

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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