Registered outcomes20

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

1 to 20 of 20

List	Outcome	Time frame	Description
Primary	Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate	12 months	The primary efficacy assessment for an individual subject was the frequency of pulmonary exacerbations (exacerbation rate). A pulmonary exacerbation was defined as the presence concurrently of at least three of the following eight symptoms/signs for at least 24 hours: * increased cough; * increased sputum volume and/or consistency; * increased sputum purulence; * new or increased haemoptysis; * increased wheezing; * increased dyspnoea; * increased fatigue/malaise and * episodes of fever (temperature ≥38°C). AND It was clinically determined that the subject required and was prescribed systemic antibiotic therapy. AND The episode of exacerbation lasted for at least 24 hours. The overall episode of exacerbation needs to last at least 24 hours, but individual symptoms/signs can last less than 24 hours (e.g, a temperature)
Secondary	Time to First NCFB Pulmonary Exacerbation	12 months	Time to First NCFB Pulmonary Exacerbation (PE) (days) = start date of first NCFB PE - date of randomization. Subjects who completed or discontinued the trial with no NCFB PE are censored at the date of treatment completion/discontinuation.
Secondary	Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score	Up to Visit 7 (12 months) / EoT	The Saint George's Respiratory Questionnaire (SGRQ) is a validated 50-item symptom questionnaire developed to measure health status and Quality of Life (QoL) in subjects with obstructive airway diseases. The scores range from 0 (best possible health status) to 100 (worst possible health status). The total score is calculated as: (sum of the weights of the positive items of all domains / sum of the weights of all items of all domains)\*100. Change from Baseline was calculated as the SGRQ total score at the visit minus Baseline. Change from baseline in SGRQ total score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	P. Aeruginosa Density: Change From Baseline at Visit 3 and at Visit 7	Visit 3 (28 days) and Visit 7 (12 months) / EoT	The P. aeruginosa density as determined by the change in log10 CFU/mL sputum from baseline (Visit 2) to Day 28 (Visit 3) was compared between the treatment groups by an ANCOVA model including treatment, pooled site, i.e. country and use of stable concomitant therapy with oral macrolides as fixed effects and baseline value as covariate. Least square means in each treatment group, least square mean difference between treatments, their 95% CIs and associated p-value were estimated.
Secondary	P. Aeruginosa Density: Change From Baseline	Up to Visit 7 (12 months) / EoT	Summary statistics of the P. aeruginosa density (i.e. quantification, log10 CFU/mL sputum) and absolute change from baseline were provided by treatment group for each trial visit.
Secondary	Mean Annual Severe Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate	12 months	A severe pulmonary exacerbation was defined as requiring intravenous antibiotics and/or hospitalisation.
Secondary	Time to First Severe NCFB Pulmonary Exacerbation	12 months	Time to First severe NCFB Pulmonary Exacerbation (PE) (days) = start date of first severe NCFB PE - date of randomization. Subjects who completed or discontinued the trial with no severe NCFB PE are censored at the date of treatment completion/discontinuation. Severe exacerbations are defined as those requiring IV antibiotics and/or hospitalisation.
Secondary	NCFB Pulmonary Exacerbation Free Days	12 months	Annualised number of exacerbation-free days = (follow-up time \[days\] - sum of durations of NCFB pulmonary exacerbations \[days\]) / follow-up time (years). For NCFB pulmonary exacerbations with a resolution date after the treatment completion/discontinuation, the number of days of duration after the treatment completion/discontinuation will be subtracted from the sum of durations of NCFB pulmonary exacerbations. Non-parametric ANCOVA model with a randomisation-based methodology was used. The model included treatment group, country, and use of stable concomitant therapy with oral macrolides as covariates.
Secondary	Days of Work Absence	12 months	Number of Days Work Absence is computed for each subject by summing all days of work absence.
Secondary	Days of Work Absence Per Employment Month	12 months	Number of Days Work Absence per Employment Month = Number of Days of Work Absence / Overall Employment Time (months). Number of Days Work Absence is computed for each subject by summing all days of work absence.
Secondary	Subjects With Hospitalisations Due to NCFB Pulmonary Exacerbations	12 months	The number and percentage of subjects with at least one hospitalisation for a NCFB pulmonary exacerbation are provided. Percentages were computed on the total number of subjects with at least one pulmonary exacerbation.
Secondary	Mean Annual Hospitalisation for NCFB Pulmonary Exacerbation Rate	12 months	The annual rate of hospitalisation for NCFB pulmonary exacerbation
Secondary	Change From Baseline in QoL-B Physical Functioning Domain Score	Up to Visit 7 (12 months) / EoT	The Quality of Life Bronchiectasis (QoL-B) is a validated self-administered, patient reported outcome measure assessing symptoms, functioning and health-related QoL for subjects with NCFB. It contains 37 items in 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each QoL-B domain is assessed on a scale of 0 to 100, higher scores indicate better health status. For the Physical Functioning Domain, the items 1, 2, 3, 4, 16 are considered. Change from baseline in QoL-B domain score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	Change From Baseline in QoL-B Role Functioning Domain Score	Up to Visit 7 (12 months) / EoT	The Quality of Life Bronchiectasis (QoL-B) is a validated self-administered, patient reported outcome measure assessing symptoms, functioning and health-related QoL for subjects with NCFB. It contains 37 items in 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each QoL-B domain is assessed on a scale of 0 to 100, higher scores indicate better health status. For the Role Functioning Domain, the items 17, 20, 25, 27, 28 are considered. Change from baseline in QoL-B domain score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	Change From Baseline in QoL-B Vitality Domain Score	Up to Visit 7 (12 months) / EoT	The Quality of Life Bronchiectasis (QoL-B) is a validated self-administered, patient reported outcome measure assessing symptoms, functioning and health-related QoL for subjects with NCFB. It contains 37 items in 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each QoL-B domain is assessed on a scale of 0 to 100, higher scores indicate better health status. For the Vitality Domain the items 6, 8, 9 are considered. Change from baseline in QoL-B domain score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	Change From Baseline in QoL-B Emotional Functioning Domain Score	Up to Visit 7 (12 months) / EoT	The Quality of Life Bronchiectasis (QoL-B) is a validated self-administered, patient reported outcome measure assessing symptoms, functioning and health-related QoL for subjects with NCFB. It contains 37 items in 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each QoL-B domain is assessed on a scale of 0 to 100, higher scores indicate better health status. For the Emotional Functioning Domain the items 7, 10, 11, 23 are considered. Change from baseline in QoL-B domain score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	Change From Baseline in QoL-B Social Functioning Domain Score	Up to Visit 7 (12 months) / EoT	The Quality of Life Bronchiectasis (QoL-B) is a validated self-administered, patient reported outcome measure assessing symptoms, functioning and health-related QoL for subjects with NCFB. It contains 37 items in 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each QoL-B domain is assessed on a scale of 0 to 100, higher scores indicate better health status. For the Social Functioning Domain the items 18, 19, 22, 26 are considered. Change from baseline in QoL-B domain score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	Change From Baseline in QoL-B Treatment Burden Domain Score	Up to Visit 7 (12 months) / EoT	The Quality of Life Bronchiectasis (QoL-B) is a validated self-administered, patient reported outcome measure assessing symptoms, functioning and health-related QoL for subjects with NCFB. It contains 37 items in 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each QoL-B domain is assessed on a scale of 0 to 100, higher scores indicate better health status. For the Treatment Burden Domain the items 12, 13, 14 are considered. Change from baseline in QoL-B domain score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	Change From Baseline in QoL-B Health Perceptions Domain Score	Up to Visit 7 (12 months) / EoT	The Quality of Life Bronchiectasis (QoL-B) is a validated self-administered, patient reported outcome measure assessing symptoms, functioning and health-related QoL for subjects with NCFB. It contains 37 items in 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each QoL-B domain is assessed on a scale of 0 to 100, higher scores indicate better health status. For the Health Perceptions Domain the items 5, 15, 21, 24 are considered. Change from baseline in QoL-B domain score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.
Secondary	Change From Baseline in QoL-B Respiratory Symptoms Domain Score	Up to Visit 7 (12 months) / EoT	The Quality of Life Bronchiectasis (QoL-B) is a validated self-administered, patient reported outcome measure assessing symptoms, functioning and health-related QoL for subjects with NCFB. It contains 37 items in 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each QoL-B domain is assessed on a scale of 0 to 100, higher scores indicate better health status. For the Respiratory Symptoms Domain the items from 29 to 37 are considered. Change from baseline in QoL-B domain score at Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7 were analysed using a linear mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, use of stable concomitant therapy with oral macrolides and pooled site, i.e. country, as fixed effects and baseline value as covariate. An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom.

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

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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

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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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