Trial · NCT02024555
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Percent Predicted Absolute Forced Vital Capacity (FVC) in Participants With Pulmonary Sarcoidosis, Comparing Baseline With Performance After Completion of 16 Weeks of Therapy. | Baseline to 16 weeks | Change in percent predicted absolute forced vital capacity (FVC) in participants with pulmonary sarcoidosis, comparing baseline with performance after completion of 16 weeks of therapy. This will involve comparing sarcoidosis and placebo after 16 weeks of therapy. |
| Secondary | Radiographic Improvement in Sarcoidosis Lung Disease by Frontal Chest X-ray . | Baseline and 16 weeks | Radiographic improvement in sarcoidosis lung disease by frontal chest x-ray . Local investigators will score chest x-rays. |
| Secondary | Six Minute Walk, Distance in Meters | Baseline, 4, 8, and 16 and 24 weeks | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. |
| Secondary | Change in Oxygen Saturation | Baseline, 4, 8, and 16 and 24 weeks | measured using pulse oximetry |
| Secondary | Change in Level of Dyspnea | Baseline, 4, 8 and 16 weeks | Outcome measure if a composite |
| Secondary | Change in the Saint George's Respiratory Questionnaire (SGRQ) | Baseline and 16 weeks | The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. |
| Secondary | Fatigue Assessment Scale (FAS). | Baseline, 4, 8, 16 and 24 weeks | The FAS is a 10-item general fatigue questionnaire to assess fatigue. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. |
| Secondary | Change in the King's Sarcoidosis Questionnaire (KSQ) for the Assessment of Health Status; | Baseline and 16 weeks | The KSQ is a free, online questionnaire to be filled out by sarcoidosis patients. The questionnaire takes around 10 minutes and is split into 5 sections; general health status, lungs, medication, skin and eyes. There are 29 questions in total, however some questions may not be answered (depending on the type of sarcoidosis affected). Each question asks patients to rate how they feel about many different aspects of their life, for instance how much pain they are in or how difficult they find everyday tasks. Information provided is confidential. Results are given as a number between 1-100 with higher numbers indicating better health. |
| Secondary | Adverse Events | 24 weeks | Safety profile of regimen as evidenced by the number of adverse events |
| Secondary | FEV1% | Baseline, 4, 8, and 16 and 24 weeks | FEV1% was measure pre and post 6 minute walk test |
| Secondary | Failure of Standard Therapy | Baseline to 16 weeks | We will assess how many subjects in either arm need escalation of their standard regimen (ie increase in prednisone) during the 16 weeks. |
| Secondary | Abnormal Lab Values | baseline to 16 weeks | Safety profile of regimen as evidenced by the number of abnormal lab values classified as Adverse Events |
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.
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GET https://conductscience.org/api/trials/v1/NCT02024555/registered