Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 17 of 17

List	Outcome	Time frame	Description
Primary	Change in exacerbation rate	through study completion, 156 weeks	Mesurement of the change in exacerbation rate in each late-onset severe eosinophilic asthmatic patient with fixed obstruction under mepolizumab treatment for 52 weeks of treatment.
Primary	Identification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1)	through study completion, 156 weeks	The identification of clinical characteristics of non-responders and super-responders. FEV1 change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment. FEV1 is the maximal amount of air you can forcefully exhale in one second measured by spirometry.
Primary	Identification of clinical characteristics of response, change in blood eosinophil levels.	through study completion, 156 weeks	The identification of clinical characteristics of non-responders and super-responders. Change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment.
Primary	Identification of clinical characteristics of response, change in FENO levels.	through study completion, 156 weeks	The identification of clinical characteristics of non-responders and super-responders. Change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment.
Primary	Identification of clinical characteristics of response, change in Asthma Control Questionnaire	through study completion, 156 weeks	Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: the Asthma Control Questionnaire (ACQ-5) to assess current asthma control. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Primary	Identification of clinical characteristics of response, change in Asthma Control Test	through study completion,156 weeks	Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Asthma Control Test (ACT) to assess current asthma control. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma.
Primary	Identification of clinical characteristics of response, change in Asthma Quality of Life Questionnaire	through study completion, 156 weeks	Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: the Asthma Quality of Life Questionnaire (AQLQ+12) to assess quality of life and psychological morbidity. Scores range 1-7, with higher scores indicating better quality of life.
Primary	Identification of clinical characteristics of response, change in Athens Insomnia Scale	through study completion, 156 weeks	Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Athens Insomnia Scale (AIS) to assess sleeping quality. Total score range form 0 to 24 with higher scores indicating worst sleeping quality. AIS includes 8 questions with scores range from 0 (meaning that the item in question has not been a problem) to 3 (indicating more acute sleep difﬁculties).
Primary	Identification of clinical characteristics of response, change in Epworth Sleepiness Scale	through study completion, 156 weeks	Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Epworth Sleepiness Scale (ESS) to assess sleeping quality. The total score can range from 0 to 24. Higher scores indicate increased sleepiness.
Primary	Identification of clinical characteristics of response, change in St. George's Respiratory Questionnaire	through study completion, 156 weeks	Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: St. George's Respiratory Questionnaire (SGRQ) to assess sleeping quality. Scores range from 0 to 100, with higher scores indicating more limitations.
Primary	Identification of clinical characteristics of response, change in WHO (Five) Well-Being Index	through study completion, 156 weeks	Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: WHO (Five) Well-Being Index (WHO-5) to assess sleeping quality. The total raw score ranges from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Primary	Identification of clinical characteristics of response, change in Fatigue Severity Scale	through study completion, 156 weeks	Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Fatigue Severity Scale (FSS) to assess sleeping quality. FSS includes a 9-item questionnaire with questions scored on a 7 point scale with 1 meaning strongly disagree and 7 meaning strongly agree. Scores range from 9 to 63. Higher the score indicates greater fatigue severity.
Primary	Change in smooth muscle cell mass	through study completion, 156 weeks	The identification of clinical characteristics of non-responders and super-responders
Primary	Change in Basement Membrane Thickness	through study completion, 156 weeks	The identification of clinical characteristics of non-responders and super-responders
Secondary	Change in smooth muscle cell mass	through study completion, 156 weeks	The identification of clinical characteristics of non-responders and super-responders. Any improvement in smooth muscle cell mass will be measured as change from baseline compared to measurement after 1 year of treatment. Increased smooth muscle cell mass indicates airway remodeling and loss of pulmonary function. Smooth muscle cell mass will be determined through the epithelial integrity, reticular basement membrane length and vascularity area.
Secondary	Change of T-lympocytes percentages	through study completion, 156 weeks	To identify any possible biomarkers of response of non-responders versus super-responders in different biological fluids as peripheral blood, bronchial washing, sputum, sputum supernatant. The identification of clinical characteristics of non-responders and super-responders. Change from baseline compared to measurements after 6 months and after 1 year of mepolizumab treatment.
Secondary	Change of cytokine and protein levels	through study completion, 156 weeks	To identify any possible biomarkers of response of non-responders versus super-responders in different biological fluids as peripheral blood, bronchial washing, sputum, sputum supernatant. The identification of clinical characteristics of non-responders and super-responders. Change from baseline compared to measurements after 6 months and after 1 year of mepolizumab treatment.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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