Trial · NCT03099187
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period | Up to Week 24 | Rate of decline in FVC was measured in mL by daily handheld spirometer. The analyses were repeated due to an additional independent review of the home spirometry data. |
| Secondary | Change in Percent Predicted FVC | Baseline (Day 1) to Week 24 | FVC was measured in liter (L) by spirometry. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis. |
| Secondary | Change in FVC | Baseline (Day 1) to Week 24 | FVC was measured in liter (L) by spirometry. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis. |
| Secondary | Categorical Change in FVC of >5% | Baseline (Day 1) to Week 24 | Categorical change in FVC was measured both by daily spirometry as well as by spirometry during clinical visits. Only the site spirometry data were used as the daily spirometry data were not normally distributed. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis. |
| Secondary | Categorical Change in FVC of >10% | Baseline (Day 1) to Week 24 | Categorical change in FVC was measured both by daily spirometry as well as by spirometry during clinical visits. Only the site spirometry data were used as the daily spirometry data were not normally distributed. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis. |
| Secondary | Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLco) | Baseline (Day 1) to Week 24 | The DLco is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLco %-predicted represents the DLco expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. |
| Secondary | Change in 6-minute Walk Distance (6MWD) | Baseline (Day 1) to Week 24 | Comparison of 6-minute walk distance before beginning and after completing study therapy. |
| Secondary | Change in University of California, San Diego-Shortness of Breath Questionnaire Score | Baseline (Day 1) to Week 24 | University of California, San Diego Shortness of Breath Questionnaire (SOBQ) consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores were calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life. |
| Secondary | Change in Score in Leicester Cough Questionnaire Score | Baseline (Day 1) to Week 24 | The Leicester Cough Questionnaire is a patient-reported questionnaire evaluating the impact of cough on quality of life. The questionnaire comprises 19 items. Each item assesses symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) were calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) was also calculated by adding the domain scores together. Higher scores indicate better quality of life. |
| Secondary | Change in Cough Visual Analog Scale (VAS) Score | Baseline (Day 1) to Week 24 | Cough VAS are 100-mm linear scales on which participants indicate the severity of their cough; 0 mm represents no cough and 100 mm the worst cough ever. |
| Secondary | Change in Total and Sub-scores of the Saint George's Respiratory Questionnaire (SGRQ) | Baseline (Day 1) to Week 24 | The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in participants with diseases of airways obstruction. Three component scores are: Symptoms (respiratory symptoms and severity); Activity (activities that cause or are limited by breathlessness); Impacts (social functioning and psychological disturbances due to airway disease). Each component sub-scores are calculated from the summed weights for the positive responses to questions. Total score summaries the impact of disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. It is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the total weight for the questionnaire. |
| Secondary | Number of Participants With Non-elective Hospitalization, Both Respiratory and All Cause | Baseline (Day 1) to Week 24 | Participants with non-elective hospitalization are reported. |
| Secondary | Percentage of Participants With Investigator-reported Acute Exacerbations | Baseline (Day 1) to Week 24 | Percentage of participants with acute exacerbation arereported. |
| Secondary | Time to First Investigator-reported Acute Exacerbations | Baseline (Day 1) to Week 24 | Time to first investigator reported acute exacerbations from start of treatment are reported. |
| Secondary | Progression-free Survival (PFS) | Baseline (Day 1) to Week 24 | PFS is defined as the time to the first occurrence of a \>10% absolute decline in percent predicted FVC, a \>50 m decline of 6MWD, or death. |
| Secondary | Progression-free Survival (PFS) | Baseline (Day 1) to Week 24 | PFS is defined as the time to the first occurrence of a \>10% relative decline in percent predicted FVC, non-elective respiratory hospitalization, or death. |
| Secondary | Time to Death From Any Cause | Baseline (Day 1) to Week 24 | Time to first documented death from start of treatment is reported. |
| Secondary | Time to Death From Respiratory Diseases | Baseline (Day 1) to Week 24 | Time to first documented death due to respiratory diseases from start of treatment will be reported. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline (Day 1) to Week 28 | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Secondary | Number of Participants With Dose Reductions and Treatment Interruptions During the Double-Blind Period | From administration of the first dose of study drug to Week 24 | Number of participants with dose reduction and treatment interruptions are reported. |
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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