scholarly journals Effect of exacerbation history on clinical response to dupilumab in moderate-severe uncontrolled asthma

2021 ◽  
pp. 2004498
Author(s):  
Jonathan Corren ◽  
Constance H. Katelaris ◽  
Mario Castro ◽  
Jorge F. Maspero ◽  
Linda B. Ford ◽  
...  
Keyword(s):  
Asthma Control ◽  
Forced Expiratory Volume ◽  
Severe Exacerbation ◽  
Uncontrolled Asthma ◽  
Phase 3 ◽  
Asthma Control Questionnaire ◽  
Elevated Type ◽  
Post Hoc ◽  
Blood Eosinophils

BackgroundThe phase 3 QUEST study (NCT02414854) in patients with uncontrolled, moderate-to-severe asthma has demonstrated the efficacy and safety of dupilumab 200 and 300 mg every 2 weeks versus placebo. This post hoc analysis assessed the effect of dupilumab on efficacy outcomes and asthma control across a range of historical exacerbation rates in patients with type 2−high asthma.MethodsAnnualised severe exacerbation rates over the 52-week treatment period, pre-bronchodilator forced expiratory volume in 1 s (FEV1) at weeks 12/52, and the 5-item Asthma Control Questionnaire (ACQ-5) score at 24/52 were assessed in patients with ≥1, ≥2, or ≥3 exacerbations in the previous year. Subgroups were stratified by baseline blood eosinophils ≥150 or ≥300 cells·μL−1 or baseline fractional exhaled nitric oxide ≥25 ppb and baseline inhaled corticosteroid dose.ResultsAcross all type 2−high subgroups, dupilumab versus placebo significantly reduced severe exacerbations by 54 to 90%, with greater improvements in patients with more exacerbations prior to study initiation. Similarly, improvements in FEV1 (least squares [LS] difference versus placebo: ≥1 exacerbation, 0.15 to 0.25 L; ≥2 exacerbations, 0.12 to 0.32 L; ≥3 exacerbations, 0.09 to 0.38 L; majority p<0.05) and ACQ-5 score (LS mean difference range: ≥1 exacerbation, −0.30 to −0.57; ≥2 exacerbations, −0.29 to −0.56; ≥3 exacerbations, −0.43 to −0.61; all p<0.05) were observed, irrespective of prior exacerbation history, across all subgroups.ConclusionsDupilumab significantly reduced severe exacerbations and improved FEV1 and asthma control in patients with elevated type 2 biomarkers irrespective of exacerbation history and baseline ICS dose.

scholarly journals Effects of Ertugliflozin on Liver Enzymes in Patients with Type 2 Diabetes: A Post-Hoc Pooled Analysis of Phase 3 Trials

2020 ◽  
Vol 11 (8) ◽  
pp. 1849-1860
Author(s):  
Silvina Gallo ◽  
Roberto A. Calle ◽  
Steven G. Terra ◽  
Annpey Pong ◽  
Lisa Tarasenko ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Liver Enzymes ◽  
Pooled Analysis ◽  
Phase 3 ◽  
Post Hoc

scholarly journals Tracing Uncontrolled Asthma in Family Practice Using a Mailed Asthma Control Questionnaire

2008 ◽  
Vol 6 (suppl_1) ◽  
pp. S16-S22 ◽  
Author(s):  
L. van den Nieuwenhof ◽  
T. Schermer ◽  
M. Heins ◽  
J. Grootens ◽  
P. Eysink ◽  
...  
Keyword(s):  
Asthma Control ◽  
Family Practice ◽  
Uncontrolled Asthma ◽  
Asthma Control Questionnaire

scholarly journals Evaluation of Asthma Control by Physicians and Patients: Comparison with Current Guidelines

2002 ◽  
Vol 9 (6) ◽  
pp. 417-423 ◽  
Author(s):  
Louis-Philippe Boulet ◽  
Robert Phillips ◽  
Paul O’Byrne ◽  
Allan Becker
Keyword(s):  
Asthma Control ◽  
Airflow Obstruction ◽  
Ordinal Scale ◽  
Consensus Guidelines ◽  
Uncontrolled Asthma ◽  
Treatment Needs ◽  
Night Time ◽  
Asthma Control Questionnaire ◽  
Current Asthma ◽  
Current Guidelines

BACKGROUND:Current asthma consensus guidelines recommend a series of criteria for determining whether asthma is controlled. It is not known whether physicians are using these criteria to assess treatment needs and how effective such assessments are compared with patient assessment of asthma control.OBJECTIVE: To compare the parameters used by physicians and patients with asthma to determine whether asthma control is acceptable, according to the current Canadian asthma consensus guidelines.DATA AND METHODS: A total of 183 Canadian physicians, mostly general practitioners, evaluated 856 patients with mildly to moderately uncontrolled asthma who were not using anti-inflammatory medications at the time of entry in the study. Physician characteristics and patient demographics were obtained. The physicians completed two questionnaires, one assessing the level of asthma control of the patient on an ordinal scale from 1 (very poor) to 5 (very good) and another indicating the parameters that were used to evaluate this level of control. Patients answered an asthma control questionnaire identical to the one completed by the physician and completed a six-question asthma control questionnaire, with each question scored on a 0- to 6-point scale.RESULTS: Although according to current asthma guidelines all patients surveyed had uncontrolled asthma, 66.2% of patients and 43.3% of physicians rated control of asthma symptoms as adequate to very good. The average scores for patient- and physician-rated asthma control were 3.0±0.2 and 2.6±0.2, respectively. The average patient score on the Juniper asthma questionnaire was 12.2±6.3. Physicians used a mean of seven parameters to assess the patient’s level of asthma control, mostly beta2-agonist need, followed by cough, wheezing, shortness of breath, limitation of physical activities and night-time awakenings. Pediatricians used cough more frequently as an evaluation parameter, and respirologists measured pulmonary function more often than other physcians. Some parameters not usually included in guideline criteria for control, such as fatigue, need to clear throat, colored sputum, headache and dizziness, were sometimes used by physicians. Only 10% and 18% of physicians used measurements of forced expiratory volume in 1 s and peak expiratory flow, respectively, in asthma control assessments.CONCLUSIONS: The present study shows that the selection of asthma control criteria among physicians varies and is not always in keeping with current asthma guidelines. Both patients and physicians often consider asthma to be controlled, when according to current guidelines, it is not, and patients consider their asthma better controlled than do physicians. Objective measures of airflow obstruction are rarely used to assess asthma control. The present study stresses the need for improved dissemination - to both patients and physicians - of current recommendations on how asthma control should be determined.

scholarly journals Is a low level of education a limiting factor for asthma control in a population with access to pulmonologists and to treatment?

2019 ◽  
Vol 45 (1) ◽  
Author(s):  
Cassia Caroline Emilio ◽  
Cintia Fernanda Bertagni Mingotti ◽  
Paula Regina Fiorin ◽  
Leydiane Araujo Lima ◽  
Raisa Lemos Muniz ◽  
...  
Keyword(s):  
Risk Factor ◽  
Asthma Control ◽  
Treatment Adherence ◽  
Limiting Factor ◽  
Inhaler Technique ◽  
Uncontrolled Asthma ◽  
Asthma Control Questionnaire ◽  
Level Of Education ◽  
Low Level ◽  
Asthma Symptoms

ABSTRACT Objective: To determine whether a low level of education is a risk factor for uncontrolled asthma in a population of patients who have access to pulmonologists and to treatment. Methods: This was a cross-sectional study involving outpatients > 10 years of age diagnosed with asthma who were followed by a pulmonologist for at least 3 months in the city of Jundiai, located in the state of São Paulo, Brazil. The patients completed a questionnaire specifically designed for this study, the 6-item Asthma Control Questionnaire (to assess the control of asthma symptoms), and a questionnaire designed to assess treatment adherence. Patients underwent spirometry, and patient inhaler technique was assessed. Results: 358 patients were enrolled in the study. Level of education was not considered a risk factor for uncontrolled asthma symptoms (OR = 0.99; 95% CI: 0.94-1.05), spirometry findings consistent with obstructive lung disease (OR = 1.00; 95% CI: 0.99-1.01), uncontrolled asthma (OR = 1.03; 95% CI: 0.95-1.10), or the need for moderate/high doses of inhaled medication (OR = 0.99; 95% CI: 0.94-1.06). The number of years of schooling was similar between the patients in whom treatment adherence was good and those in whom it was poor (p = 0.08), as well as between those who demonstrated proper inhaler technique and those who did not (p = 0.41). Conclusions: Among asthma patients with access to pulmonologists and to treatment, a low level of education does not appear to be a limiting factor for adequate asthma control.

Airway contribution to alveolar nitric oxide in healthy subjects and stable asthma patients

2008 ◽  
Vol 104 (4) ◽  
pp. 918-924 ◽  
Author(s):  
Yannick Kerckx ◽  
Alain Michils ◽  
Alain Van Muylem
Keyword(s):  
Nitric Oxide ◽  
Asthma Control ◽  
Healthy Subjects ◽  
Molecular Diffusion ◽  
Forced Expiratory Volume ◽  
No Production ◽  
Asthma Control Questionnaire ◽  
Asthma Patients ◽  
The Impact

Alveolar nitric oxide (NO) concentration (FaNO), increasingly considered in asthma, is currently interpreted as a reflection of NO production in the alveoli. Recent modeling studies showed that axial molecular diffusion brings NO molecules from the airways back into the alveolar compartment during exhalation (backdiffusion) and contributes to FaNO. Our objectives in this study were 1) to simulate the impact of backdiffusion on FaNO and to estimate the alveolar concentration actually due to in situ production (FaNO,prod); and 2) to determine actual alveolar production in stable asthma patients with a broad range of NO bronchial productions. A model incorporating convection and diffusion transport and NO sources was used to simulate FaNO and exhaled NO concentration at 50 ml/s expired flow (FeNO) for a range of alveolar and bronchial NO productions. FaNO and FeNO were measured in 10 healthy subjects (8 men; age 38 ± 14 yr) and in 21 asthma patients with stable asthma [16 men; age 33 ± 13 yr; forced expiratory volume during 1 s (FEV1) = 98.0 ± 11.9%predicted]. The Asthma Control Questionnaire (Juniper EF, Buist AS, Cox FM, Ferrie PJ, King DR. Chest 115: 1265–1270, 1999) assessed asthma control. Simulations predict that, because of backdiffusion, FaNO and FeNO are linearly related. Experimental results confirm this relationship. FaNO,prod may be derived by FaNO,prod = (FaNO − 0.08·FeNO)/0.92 ( Eq. 1 ). Based on Eq. 1 , FaNO,prod is similar in asthma patients and in healthy subjects. In conclusion, the backdiffusion mechanism is an important determinant of NO alveolar concentration. In stable and unobstructed asthma patients, even with increased bronchial NO production, alveolar production is normal when appropriately corrected for backdiffusion.

scholarly journals Is ventilation heterogeneity related to asthma control?

2016 ◽  
Vol 48 (2) ◽  
pp. 370-379 ◽  
Author(s):  
Sarah Svenningsen ◽  
Parameswaran Nair ◽  
Fumin Guo ◽  
David G. McCormack ◽  
Grace Parraga
Keyword(s):  
Quality Of Life ◽  
Asthma Control ◽  
Forced Expiratory Volume ◽  
Life Questionnaire ◽  
Strongly Correlated ◽  
Asthma Control Questionnaire ◽  
Asthma Patients ◽  
Ventilation Heterogeneity ◽  
Magnetic Resonance Imaging Mri

In asthma patients, magnetic resonance imaging (MRI) and the lung clearance index (LCI) have revealed persistent ventilation heterogeneity, although its relationship to asthma control is not well understood. Therefore, our goal was to explore the relationship of MRI ventilation defects and the LCI with asthma control and quality of life in patients with severe, poorly controlled asthma.18 patients with severe, poorly controlled asthma (mean±sd 46±12 years, six males/12 females) provided written informed consent to an ethics board approved protocol, and underwent spirometry, LCI and 3He MRI during a single 2-h visit. Asthma control and quality of life were evaluated using the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ). Ventilation heterogeneity was quantified using the LCI and 3He MRI ventilation defect percent (VDP).All participants reported poorly controlled disease (mean±sd ACQ score=2.3±0.9) and highly heterogeneous ventilation (mean±sd VDP=12±11% and LCI=10.5±3.0). While VDP and LCI were strongly correlated (r=0.86, p<0.0001), in a multivariate model that included forced expiratory volume in 1 s, VDP and LCI, VDP was the only independent predictor of asthma control (R2=0.38, p=0.01). There was also a significantly worse VDP, but not LCI in asthma patients with an ACQ score >2 (p=0.04) and AQLQ score <5 (p=0.04), and a trend towards worse VDP (p=0.053), but not LCI in asthma patients reporting ≥1 exacerbation in the past 6 months.In patients with poorly controlled, severe asthma MRI ventilation, but not LCI was significantly worse in those with worse ACQ and AQLQ.

scholarly journals Changes in quantifiable breathing pattern components predict asthma control: an observational cross-sectional study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Panagiotis Sakkatos ◽  
Anne Bruton ◽  
Anna Barney
Keyword(s):  
Asthma Control ◽  
Breathing Pattern ◽  
Cross Sectional Study ◽  
Uncontrolled Asthma ◽  
Asthma Control Questionnaire ◽  
Cross Sectional ◽  
Mean Values ◽  
Subject Variability ◽  
Asthma Patients ◽  
Within Subject Variability

Abstract Background Breathing pattern disorders are frequently reported in uncontrolled asthma. At present, this is primarily assessed by questionnaires, which are subjective. Objective measures of breathing pattern components may provide additional useful information about asthma control. This study examined whether respiratory timing parameters and thoracoabdominal (TA) motion measures could predict and classify levels of asthma control. Methods One hundred twenty-two asthma patients at STEP 2- STEP 5 GINA asthma medication were enrolled. Asthma control was determined by the Asthma Control Questionnaire (ACQ7-item) and patients divided into ‘well controlled’ or ‘uncontrolled’ groups. Breathing pattern components (respiratory rate (RR), ratio of inspiration duration to expiration duration (Ti/Te), ratio of ribcage amplitude over abdominal amplitude during expiration phase (RCampe/ABampe), were measured using Structured Light Plethysmography (SLP) in a sitting position for 5-min. Breath-by-breath analysis was performed to extract mean values and within-subject variability (measured by the Coefficient of Variance (CoV%). Binary multiple logistic regression was used to test whether breathing pattern components are predictive of asthma control. A post-hoc analysis determined the discriminant accuracy of any statistically significant predictive model. Results Fifty-nine out of 122 asthma patients had an ACQ7-item < 0.75 (well-controlled asthma) with the rest being uncontrolled (n = 63). The absolute mean values of breathing pattern components did not predict asthma control (R2 = 0.09) with only mean RR being a significant predictor (p < 0.01). The CoV% of the examined breathing components did predict asthma control (R2 = 0.45) with all predictors having significant odds ratios (p < 0.01). The ROC curve showed that cut-off points > 7.40% for the COV% of the RR, > 21.66% for the CoV% of Ti/Te and > 18.78% for the CoV% of RCampe/ABampe indicated uncontrolled asthma. Conclusion The within-subject variability of timing parameters and TA motion can be used to predict asthma control. Higher breathing pattern variability was associated with uncontrolled asthma suggesting that irregular resting breathing can be an indicator of poor asthma control.

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