A 2 × 2 factorial, randomised, open-label trial to determine the clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care over 52 weeks in adults with bronchiectasis: a protocol for the CLEAR clinical trial.

BACKGROUND: Current guidelines for the management of bronchiectasis (BE) highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum removal as part of standard care. We hypothesise that mucoactive agents (HTS or carbocisteine, or a combination) are effective in reducing exacerbations over a 52-week period, compared to usual care. METHODS: This is a 52-week, 2 × 2 factorial, randomized, open-label trial to determine the clinical effectiveness and cost effectiveness of HTS 6% and carbocisteine for airway clearance versus usual care - the Clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care (CLEAR) trial. Patients will be randomised to (1) standard care and twice-daily nebulised HTS (6%), (2) standard care and carbocisteine (750 mg three times per day until visit 3, reducing to 750 mg twice per day), (3) standard care and combination of twice-daily nebulised HTS and carbocisteine, or (4) standard care. The primary outcome is the mean number of exacerbations over 52 weeks. Key inclusion criteria are as follows: adults with a diagnosis of BE on computed tomography, BE as the primary respiratory diagnosis, and two or more pulmonary exacerbations in the last year requiring antibiotics and production of daily sputum. DISCUSSION: This trial's pragmatic research design avoids the significant costs associated with double-blind trials whilst optimising rigour in other areas of trial delivery. The CLEAR trial will provide evidence as to whether HTS, carbocisteine or both are effective and cost effective for patients with BE. TRIAL REGISTRATION: EudraCT number: 2017-000664-14 (first entered in the database on 20 October 2017). ISRCTN.com, ISRCTN89040295. Registered on 6 July/2018. Funder: National Institute for Health Research, Health Technology Assessment Programme (15/100/01). SPONSOR: Belfast Health and Social Care Trust. Ethics Reference Number: 17/NE/0339. Protocol version: v3.0 Final_14052018.

Cardiopulmonary exercise testing with supramaximal verification produces a safe and valid assessment of V̇o2max in people with cystic fibrosis: a retrospective analysis.

The validity and safety of using supramaximal verification (Smax) to confirm a maximal effort during cardiopulmonary exercise testing (CPET) in people with cystic fibrosis (CF) and/or those with severe disease has been questioned. Therefore, this study aimed to investigate these concerns in children, adolescents, and adults with mild-to-severe CF lung disease. Retrospective analysis of 17 pediatric and 28 adult participants with CF [age range: 9.2-62.9 y; forced expiratory volume in 1 s: 66.7% (range: 29.9%-102.3%); 30 men] who completed a routine ramp-incremental cycling test to determine peak oxygen uptake (V̇o2peak) was studied. Maximal oxygen uptake (V̇o2max) was subsequently confirmed by Smax at 110% of peak power output. All participants satisfied the criteria to verify a maximal effort during CPET. However, Smax-V̇o2peak exceeded ramp-V̇o2peak in 3/14 (21.4%) of pediatric and 6/28 (21.4%) adult exercise tests. A valid measurement of V̇o2max was attained in 85.7% of pediatric and 96.4% of adult exercise tests, as Smax-V̇o2peak did not exceed ramp-V̇o2peak by >9%. Adults ( n = 9) experienced a ≥5% reduction in arterial O2 saturation during CPET, 4 during both the ramp and Smax, 3 during only the ramp, and 2 during only Smax. Smax did not significantly worsen perceived breathing effort, chest tightness, throat narrowing, or exertion compared with ramp-incremental testing. Given the clinical importance of aerobic fitness in people with CF, incorporating Smax is recommended to provide a safe and valid measure of V̇o2max in children, adolescents, and adults who span the spectrum of CF disease severity. NEW & NOTEWORTHY Incorporating supramaximal verification into cardiopulmonary exercise testing protocols did not increase the frequency of adverse events or perceived discomfort versus a single-phase incremental exercise test in people with mild-to-severe cystic fibrosis. Furthermore, a valid measure of maximal oxygen uptake (V̇o2max) was obtained from 85.7% of pediatric and 96.4% of adult exercise tests, whereas peak oxygen uptake underestimated aerobic fitness in comparison with V̇o2max in 21.4% of cases (by up to 24.4%).

US health policy related to hookah tobacco smoking.

OBJECTIVES: Although US cigarette smoking is decreasing, hookah tobacco smoking (HTS) is an emerging trend associated with substantial toxicant exposure. We assessed how a representative sample of US tobacco control policies may apply to HTS. METHODS: We examined municipal, county, and state legal texts applying to the 100 largest US cities. We developed a summary policy variable that distinguished among cities on the basis of how current tobacco control policies may apply to HTS and used multinomial logistic regression to determine associations between community-level sociodemographic variables and the policy outcome variable. RESULTS: Although 73 of the 100 largest US cities have laws that disallow cigarette smoking in bars, 69 of these cities have exemptions that allow HTS; 4 of the 69 have passed legislation specifically exempting HTS, and 65 may permit HTS via generic tobacco retail establishment exemptions. Cities in which HTS may be exempted had denser populations than cities without clean air legislation. CONCLUSIONS: Although three fourths of the largest US cities disallow cigarette smoking in bars, nearly 90% of these cities may permit HTS via exemptions. Closing this gap in clean air regulation may significantly reduce exposure to HTS.

Associations between smoking and media literacy in college students.

Organizations recommend media literacy to reduce tobacco use, and higher media literacy has been associated with lower smoking among high school students. The relationship between smoking media literacy and tobacco use, however, has not been systematically studied among college students. The purpose of this study was to determine the association between smoking and smoking media literacy among college students. We conducted the National College Health Assessment (NCHA) at a large, urban university, adding six items measuring smoking media literacy. A total of 657 students responded to this random sample e-mail survey. We used multiple logistic regression to determine independent associations between smoking media literacy items and current smoking. The media literacy scale was internally consistent (alpha = 0.79). Of the respondents, 21.5% reported smoking cigarettes over the past 30 days. In a fully adjusted multivariate model, participants with medium media literacy had an odds ratio (OR) for current smoking of 0.45 (95% CI = 0.29, 0.70), and those with high media literacy had an OR for current smoking of 0.38 (95% CI = 0.20, 0.70). High smoking media literacy is independently associated with lower odds of smoking. Smoking media literacy may be a valuable construct to address in college populations.