Study protocol: a randomized, double-blind, parallel, two-arm, placebo control trial investigating the feasibility and safety of immunoglobulin treatment in COPD patients for prevention of frequent recurrent exacerbations
Bibliographic record
Abstract
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a chronic progressive inflammatory disease of the airways, associated with frailty, disability, co-morbidity, and mortality. Individuals with COPD experience increased risk and rates of acute exacerbation as their lung disease worsens. Current treatments to prevent acute exacerbation of COPD (AECOPD) are only modestly effective. New therapies are needed to improve the quality of life and clinical outcomes for individuals living with COPD and especially for those prone to frequent recurrent AECOPD. Recent research has suggested an association of gammaglobulin or immunoglobulin G levels with AECOPD and a favorable effect of an immunoglobulin treatment on the frequency of recurrent AECOPD, healthcare provider visits, treatments, and hospitalizations. However, control trials are required to confirm this apparent association and therapeutic effect. This study aims to assess if intravenous immunoglobulin (IVIG) therapy is feasible, safe, tolerable, and potentially effective in reducing the frequency of recurrent AECOPD. METHODS/DESIGN: Adult COPD patients at The Ottawa Hospital (TOH) will be recruited to partake in a randomized double-blind, parallel, two-arm, placebo control trial. Eligible patients will be administered either IVIG or normal saline following 1:1 randomization and every 4 weeks for 1 year. The primary outcome of feasibility will be determined by recruitment, patient adherence, safety and tolerance, success of the follow-up procedures, and outcome measurement. The safety and tolerability will be assessed through adverse events, adherence, and study withdrawals. Efficacy trends will be investigated by assessing incidence rates of AECOPD, improvement in quality of life, and healthcare services use and cost. DISCUSSION: The study results will inform larger studies designed to confirm a clinically significant therapeutic effect in identifiable populations which would be a major advance in the care of COPD patients. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov, NCT03018652 and NCT02690038.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.007 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.006 | 0.004 |
| Insufficient payload (model declined to judge) | 0.027 | 0.004 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".