Last updated: 07/17/2024 17:12:06
Cross-sectional Study for Identification and Description of Severe Asthma Patients
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Identification and Description of Severe Asthma Patients in a Cross-sectional Study—the IDEAL Study
Trial description: This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Percentage of severe asthma participants eligible for one or more biologic treatments for asthma- mepolizumab, omalizumab (European union [EU]1, EU2, & omalizumab (AUS, US and CAN) criteria, and reslizumab
Timeframe: Day 1 upto Day 14
Secondary outcomes:
Historical exacerbations (Exb)-Number of participants with exacerbations requiring oral corticosteroids (OCS) and or emergency room (ER) visit and or hospitalization (hosp)
Timeframe: Day 1
Historical Exacerbations-Number of participants with atleast 1 or atleast 2 exb requiring OCS or hosp or ER
Timeframe: Day 1
Mean and Median number of times utilization of planned asthma related healthcare resource in the prior 12 months
Timeframe: Day 14
Mean frequency of utilization of unplanned asthma related healthcare resource in the prior 12 months
Timeframe: Day 14
Mean frequency of utilization of unplanned asthma related healthcare resource in the prior 12 months: Number of days in ICU and number of days in GWH
Timeframe: Day 14
Median frequency of utilization of unplanned asthma related healthcare resource in the prior 12 months
Timeframe: Day 14
Median frequency of utilization of unplanned asthma related healthcare resource in the prior 12 months:Number of days in ICU and number of days in GWH
Timeframe: Day 14
Mean and median Charlson Comorbidity Index (CCI) score
Timeframe: Day 14
Number of participants with CCI by current Omalizumab use
Timeframe: Day 14
Mean pre-bronchodilator (PrBD) FEV1/forced vital capacity (FVC) ratio
Timeframe: Day 14
Mean post-bronchodilator FEV1/FVC ratio
Timeframe: Day 14
Mean PrBD FEV1
Timeframe: Day 14
Mean PBD FEV1
Timeframe: Day 14
Mean PrBD FVC
Timeframe: Day 14
Mean post-bronchodilator FVC
Timeframe: Day 14
Assessment of levels of blood eosinophils
Timeframe: Day 14
Median levels of blood eosinophils
Timeframe: Day 14
Assessment of level of Total Ig E
Timeframe: Day 14
Median levels of Total IgE
Timeframe: Day 14
Mean and median levels of specific IgE
Timeframe: Day 14
Mean score for asthma Control Questionnaire (ACQ-5)
Timeframe: Day 14
Mean score for St. George's Respiratory Questionnaire (SGRQ)
Timeframe: Day 14
Mean score for Asthma Quality of Life Questionnaire-Standardized (AQLQ-S)
Timeframe: Day 14
Mean score for EuroQol 5D (EQ-5D-5L)
Timeframe: Day 14
Mean summarised scores for work productivity and activity impairment index: general health (WPAI-GH)
Timeframe: Day 14
Mean score for Asthma Symptom Utility Index (ASUI)
Timeframe: Day 14
Interventions:
Enrollment:
767
Primary completion date:
2015-01-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nelsen L, Cockle S, Gunsoy N, Jones P, Albers F, Bradford E, Meullerova H.Impact of exacerbations on St Georges Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study .J Asthma.2019;
DOI: 10.1080/02770903.2019.1630640
PMID: 31251094
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
December 2014 to May 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- At least 12 years of age at study visit.
- Participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the European Respiratory Society/ American Thoracic Society (ERS/ATS) Guidelines for severe asthma: Asthma which requires treatment with guideline suggested medications for Global Initiative for Asthma (GINA) steps 4-5 asthma for the previous year (i.e., at least 12 months).
- Participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)
Inclusion and exclusion criteria
Inclusion criteria:
- At least 12 years of age at study visit.
- Participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the European Respiratory Society/ American Thoracic Society (ERS/ATS) Guidelines for severe asthma: Asthma which requires treatment with guideline suggested medications for Global Initiative for Asthma (GINA) steps 4-5 asthma for the previous year (i.e., at least 12 months). Patients must be treated with high dose ICS PLUS at least one of the following: LABA, leukotriene modifier, theophylline, or continuous or near continuous systemic corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year). SPECIAL CIRCUMSTANCE: If patient is on a fixed dose combination medication, then the maximum recommended dose of the ICS/LABA combination per local label is acceptable.
- Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. A parent or legal guardian must provide informed consent for participants less than 18 years of age at study visit (or less than minimum age to be considered an adult per local laws).
Exclusion criteria:
- Participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)
Trial location(s)
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Showing 1 - 6 of 74 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-01-05
Actual study completion date
2015-01-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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