Trial · NCT03170271
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) | Baseline (Week 0) up to Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. | Events/year | NUMBER |
| SECONDARY | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Total Score to the EOT (Week 24) | Baseline (Week 0) and Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in First Second (FEV1) to the EOT (Week 24) | Baseline (Week 0) and Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Liters (L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score to the EOT (Week 24) | Baseline (Week 0) and Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Asthma Exacerbation (up to Week 24) | Baseline (Week 0) up to Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Run-in Baseline Home Peak Expiratory Flow (PEF) (Morning and Evening) to the EOT (Week 24) | Run-in baseline (from Day -28 to Day 0) and Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | L/minute | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form 36-item Health Survey, Version 2 (SF-36v2) to the EOT (Week 24) | Baseline (Week 0) and Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Severity (PGI-S): Responder Status at the EOT (Week 24) | Baseline (Week 0) and Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. | Percentage of patients | NUMBER |
| SECONDARY | Clinician Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C): Responder Status at the EOT (Week 24) | Baseline (Week 0) and Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. | Percentage of patients | NUMBER |
| SECONDARY | Change From Baseline in Predominant Symptom and Impairment Assessment (PSIA) Severity Score for Average of Top 3 Ranked Symptoms/Impairments and for Top Ranked Symptom/Impairment at the EOT (Week 24) | Baseline (Week 0) and Week 24 | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Sino-Nasal Outcome Test Item 22 (SNOT-22) Total Score to the EOT (Week 24) | Baseline (Week 0) and Week 24 | The chronic rhinosinusitis with nasal polyposis sub-study analysis set was defined as the subset of patients with doctor-diagnosed chronic rhinosinusitis and nasal polyposis included in their medical history who had signed the informed consent to participate in the sub-study and who had received at least 1 dose of IP. | Scores on a scale | LEAST_SQUARES_MEAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03170271/outcomes