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NVA237 once daily improves dyspnea and health-related quality of life (HRQoL) in patients with COPD: The GLOW1 trial

2011· article· en· W7135052041 on OpenAlexaff
JA van Noord, K. Hirata, AD D'Urzo, C. Martin, Robert Horton, Y. Lu, Tim Overend

Bibliographic record

VenueEuropean Respiratory Journal · 2011
Typearticle
Languageen
FieldMedicine
TopicChronic Obstructive Pulmonary Disease (COPD) Research
Canadian institutionsUniversity of Toronto
Fundersnot available
KeywordsMinimal clinically important differenceCOPDQuality of life (healthcare)Muscarinic antagonistPlaceboInhalerDry-powder inhaler

Abstract

fetched live from OpenAlex

Introduction: A high level of unmet need exists in the treatment of COPD patients. NVA237 (glycopyrronium bromide) is a once-daily (QD) long-acting muscarinic antagonist in development for the treatment of COPD. Methods: Patients with moderate-to-severe COPD were randomized (2:1) to 26 wks' double-blind treatment with NVA237 50 μg QD or placebo (PBO) administered via a low-resistance single-dose dry powder inhaler (Concept1 device). In addition to FEV 1 (primary endpoint: trough FEV 1 after 12 wks) efficacy was assessed by symptoms (via the transition dyspnea index [TDI]), HRQoL (via the St George's Respiratory Questionnaire [SGRQ]), and rescue medication use. Results: A total of 822 patients (mean age 63.9 yrs; post-bronchodilator FEV 1 54.6% predicted) were randomized; 80.5% completed. At Wk 26, NVA237 significantly increased total TDI focal score vs PBO (difference: 1.04, p<0.0001) exceeding the minimum clinically important difference ([MCID] ≥1 point). The% of patients achieving a MCID in TDI score was significantly higher with NVA237 vs PBO (62.5% vs 50.8%; odds ratio [OR] 1.74; p=0.001). NVA237 significantly reduced rescue medication use vs PBO after 26 wks of treatment (–0.46 puffs/day, p=0.005). SGRQ total score was significantly reduced with NVA237 vs PBO (–2.81; OR 1.58; p=0.004). The% of patients achieving a clinically meaningful improvement in SGRQ (≥4 point reduction) was significantly higher with NVA237 vs PBO (56.3% vs 46.0%; p=0.006). Conclusion: NVA237 50 μg once daily provided a significant and clinically relevant improvement in dyspnea at 26 wks vs PBO, which was accompanied by a significant improvement in HRQoL and reduced rescue medication use.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.001
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.004
Threshold uncertainty score0.014

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0020.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0010.000
Open science0.0010.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0040.001

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.

Opus teacher head0.075
GPT teacher head0.313
Teacher spread0.239 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

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".

Quick stats

Citations0
Published2011
Admission routes1
Has abstractyes

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