Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma

IntroductionAsthma exacerbations spike in the spring and autumn months, yet the seasonal variation of asthma symptoms and lung function is poorly studied.MethodsSeasonal variation of lung function, rescue medication use and patient-reported symptoms was evaluated by posthoc analyses of the Phase III lebrikizumab (anti-IL-13) LAVOLTA I and II studies in 2148 subjects with uncontrolled asthma. Lung function measurements (prebronchodilator FEV1, forced vital capacity (FVC) and peak expiratory flow (PEF)), rescue medication use and Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) were measured every 4 weeks over 52 weeks. By-month estimates normalised by hemispheric season were based on mixed-effect models with repeated measures (MMRM), adjusted by study stratification factors as covariates when appropriate. The dependency of clinical outcomes with seasonal variability was assessed by employing linear contrasts comparing hemisphere normalised December versus July group means from an MMRM regression and presented as the difference in means (adjusted 95% CI).ResultsFEV1, FVC and PEF, rescue medication use and AQLQ(S) progressively worsened towards winter, unlike spring and autumn surges in asthma exacerbations. The December versus July mean differences were: (1) PEF=−6.5 (–8.7 to –4.2) L/min, 2) prebronchodilator FEV1=−42 (–57 to –27) mL, (3) FVC=−41 (−59 to –23) mL and (4) AQLQ(S)=−0.15 (–0.19 to –0.1) units. Among AQLQ questions, discomfort or distress related to cough was most variable with respect to season (−0.33 (−0.42 to –0.24) units).DiscussionInterpretation of interventional studies biased by seasonal exposures may be confounded by seasonal variability.Trials registration numbersNCT01867125 and NCT01868061.

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PRS106 - THE ASSESSMENT THE QUALITY OF LIFE IN CHILDREN WITH SEVERE PERSISTENT UNCONTROLLED ASTHMA, RECEIVING OMALIZUMAB, BY THE HEALTH UTILITIES INDEX AND STANDARDISED PAEDIATRIC ASTHMA QUALITY OF LIFE QUESTIONNAIRE(ACCORDING TO THE PEDIATRIC REGISTRY)

Value in Health ◽

10.1016/j.jval.2018.09.2919 ◽

2018 ◽

Vol 21 ◽

pp. S421

Author(s):

E. Vishneva ◽

L. Namazova-Baranova ◽

E. Dobrynina ◽

A. Alekseeva ◽

J. Levina ◽

...

Keyword(s):

Quality Of Life ◽

Life Questionnaire ◽

Uncontrolled Asthma ◽

Health Utilities Index ◽

Paediatric Asthma ◽

Quality Of Life Questionnaire ◽

Health Utilities

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Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety

Health Technology Assessment ◽

10.3310/hta17040 ◽

2013 ◽

Vol 17 (4) ◽

pp. 1-218 ◽

Cited By ~ 13

Author(s):

W Lenney ◽

AJ McKay ◽

C Tudur Smith ◽

PR Williamson ◽

M James ◽

...

Keyword(s):

Quality Of Life ◽

Fluticasone Propionate ◽

Primary Outcome ◽

Life Questionnaire ◽

Uncontrolled Asthma ◽

Double Blind ◽

Once Daily ◽

Quality Of Life Questionnaire ◽

Oral Corticosteroids

BackgroundAsthma affects one in eight children in the UK. National management guidelines have been available for many years but, unlike in adults, studies in children have been few, with their methodologies often based on inappropriate adult models. Sound medical evidence in support of the national guidelines for asthma management in children is lacking. The MASCOT study has been developed to address this need.ObjectivesTo determine whether adding salmeterol or montelukast to low-dose inhaled corticosteroids (ICSs) can reduce the number of exacerbations requiring treatment with oral corticosteroids in children with uncontrolled asthma.DesignA randomised, double-blind, placebo-controlled trial with a 4-week run-in period on a fluticasone propionate inhaler (100 μg twice daily) with inhaler technique correction. Patients who met the post run-in period eligibility criteria were randomised in the ratio of 1 : 1 : 1 and were followed for 48 weeks.SettingSecondary care hospitals based in England and Scotland with recruitment from primary and secondary care.ParticipantsChildren aged 6–14 years with asthma requiring frequent short-acting beta-2 agonist relief, with symptoms of asthma resulting in nocturnal wakening and/or asthma that has interfered with usual activities.InterventionsThree groups were compared: (1) inhaled fluticasone propionate 100 μg twice daily plus placebo tablet once daily; (2) inhaled fluticasone propionate 100 μg and salmeterol 50 μg twice daily (combination inhaler) plus placebo tablet once daily; and (3) inhaled fluticasone propionate 100 μg twice daily plus montelukast 5-mg tablet once daily.Main outcome measuresThe primary outcome was the number of exacerbations requiring treatment with oral corticosteroids over 48 weeks. Secondary outcome measures included quality of life as measured by the Paediatric Asthma Quality of Life Questionnaire with Standardised Activities [PAQLQ(S)] and the Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ); time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids; school attendance; hospital admissions; amount of rescue beta-2 agonist therapy prescribed; time from randomisation to treatment withdrawal (because of lack of efficacy or side effects); lung function at 48 weeks (as assessed by spirometry); cost-effectiveness; adverse events.ResultsThe study was closed prematurely because of poor recruitment and the target sample size of 450 was not achieved. In total, 898 children were screened to enter the trial, 166 were registered for the 4-week run-in period and 63 were randomised (group 1: 19, group 2: 23, group 3: 21), with 38 contributing data for the primary outcome analysis. There were no significant differences between groups for any of the outcomes. Adverse events were similar between the groups except for nervous system disorders, which were more frequently reported on fluticasone plus montelukast.ConclusionsBased on the results of the MASCOT study it is not possible to conclude whether adding salmeterol or montelukast to ICSs can reduce the number of exacerbations requiring treatment with oral corticosteroids in children with uncontrolled asthma.Trial registrationCurrent Controlled Trials ISRCTN03556343.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 17, No. 4. See the HTA programme website for further project information.

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Alexithyme Patientenmerkmale und Lebensqualität – Eine Querschnittsstudie an 79 ambulanten Patienten mit Angststörungen

Zeitschrift für Psychiatrie Psychologie und Psychotherapie ◽

10.1024/1661-4747/a000136 ◽

2013 ◽

Vol 61 (1) ◽

pp. 17-26 ◽

Cited By ~ 2

Author(s):

Katrin Leenen ◽

Michael Rufer ◽

Hanspeter Moergeli ◽

Hans-Jörgen Grabe ◽

Josef Jenewein ◽

...

Keyword(s):

Quality Of Life ◽

World Health ◽

Life Questionnaire ◽

World Health Organization Quality ◽

Fand Sich ◽

Quality Of Life Questionnaire ◽

Organization Quality ◽

Health Organization ◽

Tas 20

Aus Untersuchungen in der Normalbevölkerung ist bekannt, dass Menschen mit erhöhten Alexithymiewerten eine verminderte Lebensqualität (LQ) aufweisen. Für Patienten mit psychischen Störungen wurde dieser Zusammenhang jedoch kaum untersucht. Ziel dieser Studie war es, den möglichen Zusammenhang zwischen alexithymen Patientenmerkmalen und der LQ bei Patienten mit Angststörungen zu überprüfen. Bei 79 ambulanten Patienten mit Angststörungen wurden alexithyme Charakteristika mit der Toronto Alexithymia Scale (TAS-20), die LQ mit der Kurzversion des World Health Organization Quality of Life Questionnaire 100 (WHOQOL-BREF) erfasst. Darüber hinaus fand eine Erhebung der psychischen Symptombelastung (SCL-90-R) und depressiven Symptomatik (MADRS) statt. Mittels hierarchischer Regressionsanalysen wurde der Zusammenhang zwischen der alexithymen Charakteristika und den unterschiedlichen LQ-Domänen berechnet. Die Patienten zeigten eine im Vergleich zur Normalbevölkerung deutlich verminderte LQ. Als Hauptergebnis fand sich, auch nach Kontrolle von Depression, Ängstlichkeit und Geschlecht, ein signifikanter Zusammenhang zwischen den beiden TAS-20 Subskalen Schwierigkeiten, Gefühle zu identifizieren und zu beschreiben und vor allem der psychischen LQ. Unsere Ergebnisse sprechen dafür, bei der Diagnostik und Therapieplanung von Patienten mit Angststörungen alexithyme Merkmale einzubeziehen. Im Falle von ausgeprägten alexithymen Merkmalen sollten psychotherapeutische Interventionen zur Verbesserung der Schwierigkeiten Gefühle wahrzunehmen und zu kommunizieren in Betracht gezogen werden.

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