Inhaled fluticasone furoate-vilanterol ICS/LABA combination,
does it really help with Improved overall survival in moderate COPD with heightened cardiovascular risk?
research showsThe grade is D. The value of SUMMIT is a well-designed, very large null trial. In 16,485 intention-to-treat participants, deaths were 246/4,121 (6.0%) versus 275/4,111 (6.7%), absolute difference -0.7 points, HR 0.88 (95% CI 0.74 to 1.04), P=0.137. Benefit was not established, but absence of benefit was not proven.
ads claimA favorable -0.7-point estimate was not significant. A null result must not be rewritten as proof of zero survival effect.
Useful facts when choosing a product
- The combination contains an inhaled corticosteroid and LABA.
- SUMMIT ran in 1,368 centers across 43 countries.
- GlaxoSmithKline funded the trial.
Chamgap Semantic Classification Code
Candidate index · review held
M.fluticasone-furoate-plus-vilanterol.inhaled.copd-overall-survival.improve.placeboMedicinal interventions > Fluticasone furoate plus vilanterol > Inhaled > Overall survival in COPD > Improvement claim > Placebo
An automated migration candidate, not an issued permanent code; exact claim scope remains under review. This machine-generated migration candidate helps retrieval but is not a permanent assignment. The original verdict ID and URL remain authoritative.
What the research actually shows
This asks whether inhaled steroid combination prolongs life. It differs from 2876's comparison of inhaled combinations for exacerbations and 2878's addition of oral PDE4 inhibition to maximal inhaled therapy. Ensifentrine 1905, dupilumab 1771, azithromycin 1195, and acute prednisone 2812 address different interventions.
Axis 6 B0 evidence ① Allocation concealment: 'randomly assigned ... through a centralised randomisation service in permuted blocks'. ② Blinding: 'double-blind randomised controlled trial' with matched placebo. ③ Analysis set and missingness: 'efficacy analyses were performed on the intention-to-treat population'; survival censoring was used. ④ Prespecified primary endpoint: 'The primary outcome was all-cause mortality' - consistent with NCT01313676.
Why this is classified as D (34)
H, R1, I0, E0, B0, C0, and large-hard-RCT status yield D with 34 points.
Counterpoint. The null survival endpoint does not erase favorable exacerbation and lung-function secondary findings.
Rejudgment record. Cross-check applied — Balanced the null primary survival result from a very large blinded RCT against the meaningful benefit still allowed by its confidence interval
| Endpoint | H | Hard endpoint - actual events such as death |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E0 | Null |
| Precision | C0 | The confidence interval leaves room for benefit |
Stored derived and displayed grades match; this is not a current recalculation or validity check (D).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Improved overall survival | D | The result was null: HR 0.88 (0.74 to 1.04), P=0.137. |
| Reduced moderate or severe exacerbations | C | The prespecified secondary rate was 29% lower, interpreted after primary survival failure. |
Cross-check — AI research and Codex final gate
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Vestbo J et al. 2016 SUMMIT | Multinational double-blind randomized placebo-controlled event-driven trial | 16,590 randomized; 16,485 in efficacy ITT; 4,121 combination and 4,111 placebo | Funded by GlaxoSmithKline | Primary endpoint: all-cause mortality | 246/4,121 (6.0%) versus 275/4,111 (6.7%), absolute difference -0.7 points, HR 0.88 (95% CI 0.74 to 1.04), P=0.137. | Pivotal large hard-outcome trial |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-08-18).
Final verification and publication gate: Codex · Evidence date: 2026-08-18 · Corrections: none
Cite this verdict
[Chamgap] No Benefit of Fluticasone Furoate-Vilanterol for Survival in Moderate COPD with Heightened Cardiovascular Risk — Evidence Grade D·34. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/immunity/fluticasone-furoate-vilanterol-moderate-copd-cardiovascular-risk-survival/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.