Trial reportRespiratory research2015
The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease.
Trial report in Respiratory research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01551758 (A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate), which is not on this map. Cited by 18 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler (NDPI) Compared With the Existing COPD Maintenance Therapy Alone in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Who cites it
18 citing papers in PubMed, 42 citations in OpenAlex.
- Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.Pharmacoepidemiology and drug safety · 2017Trial
- The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease.Therapeutic advances in respiratory diseaseTrial
- When Are Treatment Blinding and Treatment Standardization Necessary in Real-World Clinical Trials?Clinical pharmacology and therapeutics · 2022Review
- Safety data in randomised real-world evidence studies: Salford Lung Study learnings.ERJ open research · 2021Review
- Linkage of primary care prescribing records and pharmacy dispensing Records in the Salford Lung Study: application in asthma.BMC medical research methodology · 2020Article
- Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies.The International journal of pharmacy practice · 2020Article
- Article
- Real-World Data and Randomised Controlled Trials: The Salford Lung Study.Advances in therapy · 2020Review
- Comparing Randomized Controlled Trials and Real-World Studies in Chronic Obstructive Pulmonary Disease Pharmacotherapy.International journal of chronic obstructive pulmonary disease · 2020Review
- Triple Therapy Versus Dual Bronchodilation and Inhaled Corticosteroids/Long-Acting β-Agonists in COPD: Accumulating Evidence from Network Meta-Analyses.Pulmonary therapy · 2019Review
- Can medicines development improve outcomes in asthma and chronic obstructive pulmonary disease management by driving effectiveness?Respiratory research · 2019Article
- Effectiveness trials: critical data to help understand how respiratory medicines really work?European clinical respiratory journal · 2019Review
- Recruitment of patients with Chronic Obstructive Pulmonary Disease (COPD) from the Clinical Practice Research Datalink (CPRD) for research.NPJ primary care respiratory medicine · 2018Article
- Real world evidence (RWE) - a disruptive innovation or the quiet evolution of medical evidence generation?F1000Research · 2018Article
- The Salford Lung Study: a pioneering comparative effectiveness approach to COPD and asthma in clinical trials.Pragmatic and observational research · 2017Review
- Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative.Journal of the American Society of Nephrology : JASN · 2016Review
- Natural experiments and large databases in respiratory and cardiovascular disease.European respiratory review : an official journal of the European Respiratory Society · 2016Review
- Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD.International journal of chronic obstructive pulmonary disease · 2016Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNew treatments need to be evaluated in real-world clinical practice to account for co-morbidities, adherence and polypharmacy.
methodsPatients with chronic obstructive pulmonary disease (COPD), ≥ 40 years old, with exacerbation in the previous 3 years are randomised 1:1 to once-daily fluticasone furoate 100 μg/vilanterol 25 μg in a novel dry-powder inhaler versus continuing their existing therapy. The primary endpoint is the mean annual rate of COPD exacerbations; an electronic medical record allows real-time collection and monitoring of endpoint and safety data.
conclusionsThe Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in COPD.
trial registrationClinicaltrials.gov identifier NCT01551758.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.