Last updated: 11/03/2018 23:23:10

Severe Asthma: Characterizing Patient Impacts of Frequent/Chronic Use of Oral Corticosteroids

GSK study ID
205633
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: Severe Asthma: Characterizing Patient Impacts of Frequent/Chronic Use of Oral Corticosteroids
Trial description: GlaxoSmithKline (GSK) has developed a questionnaire, the Oral Steroid Burden Questionnaire (OSBQ) to measure the burden of oral corticosteroids. The questionnaire was initially developed for a target patient population with System Lupus Erythematosus (SLE) and adapted for Giant Cell Arteritis (GCA). The objective of the present study will be to adapt the OSBQ-Asthma for use in future studies involving patients with severe asthma who are using oral corticosteroids (OCS) on a continuing (chronic) basis and to characterize the impact of OCS in subjects with severe asthma. Subjects with severe asthma who are on chronic OCS will be recruited and subjected to a qualitative cognitive interview. After the first round of interviews, the field notes will be analyzed to suggest revisions to the draft OSBQ-Asthma items based on subjects’ feedback. Following review and revisions, the revised OSBQ-Asthma items will be evaluated in the second round of interviews to test the adequacy of modifications and gather any additional qualitative data about the final item set. Finally, the interview transcripts will be carefully reviewed to prepare the final item set and summary report providing support for the development of the OSBQ-Asthma.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To adapt the SLE Steroid Questionnaire for use in future studies involving patients with severe asthma using OCS based on cognitive debriefing feedback from qualitative interviews with patients.

Timeframe: 90 minutes

Secondary outcomes:

To characterize the impact of OCS in patients with severe asthma.

Timeframe: 90 minutes

Interventions:
  • Other: OSBQ-Asthma
    • Enrollment:
    18
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    RTI Health Solutions
    Study date(s)
    April 2016 to January 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    None
    • Inclusion Criteria
    • Male or female.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria
    • Male or female.
    • Aged 18 years or older.
    • Doctor or health care professional reports that the patient: 1. Meets 2014 American Thoracic Society/European Respiratory Society (ATS/ERS) diagnostic criteria for severe asthma which requires treatment with high-dose inhaled corticosteroid (ICS) PLUS at least one of the following: long-acting beta agonist (LABA), leukotriene modifier, theophylline, for the previous year (i.e., at least 12 months). 2. Special circumstances: If patient is on a fixed-dose combination medication, the maximum recommended dose of the ICS/LABA combination per local label is acceptable; If eligible patients cannot be identified meeting the specified treatment criteria above (i.e., receiving high-dose ICS plus a second controller for at least 12 months), the timeframe for this treatment criteria may be modified to at least 6 months upon receiving e-mail confirmation from the study sponsor. 3. Has been taking OCS continuously (daily) for the past 3 months OR on >50 percent of days (daily, burst therapy, or a combination) during the past 12 months for treatment of asthma.
    • The participant is willing and able to participate in a 90 minute, in-person interview.
    • The participant is able to provide informed consent and can read, understand and provide responses English. Exclusion Criteria
    • Current smokers or smoking history of >=10 pack-years
    • Clinically important lung condition other than asthma (e.g., chronic obstructive pulmonary disease)
    • Diagnosis of malignancy or in the process of investigation
    • Regular use of oral or systemic corticosteroids for diseases other than asthma within 12 months or any intra-articular, short-acting intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroid within 3 months.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    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
    Not applicable
    Actual study completion date
    2017-26-01

    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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