Trial reportRespiratory research2012
Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms.
Trial report in Respiratory research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01046136 (Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
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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.
Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Tools for assessing outcomes in studies of chronic cough: CHEST guideline and expert panel report.Chest · 2015Guideline
- Over-the-counter (OTC) medications for acute cough in children and adults in community settings.The Cochrane database of systematic reviews · 2014Pooled it
- Non-prescription treatments for childhood infections: an Austrian, monocentric, cross-sectional questionnaire study.BMC pediatrics · 2022Article
- A pilot study of safety of sulfamethoxazole, trimethoprim and guaifenesin in pediatric and adult patients with acute bronchitis.BMC research notes · 2019Observational
- Safety And Tolerability Of Extended-Release Guaifenesin In Patients With Cough, Thickened Mucus And Chest Congestion Associated With Upper Respiratory Tract Infection.Drug, healthcare and patient safety · 2019Article
- Role of guaifenesin in the management of chronic bronchitis and upper respiratory tract infections.Multidisciplinary respiratory medicine · 2017Review
- Article
- Physician's prescription pattern in young infants with upper respiratory infections/cough and cold in emergency department.Pakistan journal of medical sciencesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGuaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study.
methodsThe pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient's End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study.
resultsSubjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated.
conclusionsResults from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs.
trial registrationThe study was registered with clinicaltrials.gov (NCT01046136).
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