Interventions To Help Asthma Clinical Adherence

Conditions:   Asthma/Drug Therapy;   Medication Adherence/Statistics & Numerical Data;   Reminder Systems;   Humans;   Hispanic Americans;   Communication Barriers;   Child
Interventions:   Device: SmartInhaler with reminder function turned on;   Device: SmartInhaler
Sponsors:   University of California, San Francisco;   Academic Pediatric Association
Not yet recruiting – verified December 2016

View full post on ClinicalTrials.gov: asthma | Studies received in the last 14 days

[Patient-related independent clinical risk factors for early complications following interventional pulmonology procedures].

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[Patient-related independent clinical risk factors for early complications following interventional pulmonology procedures].

Beijing Da Xue Xue Bao. 2016 Dec 18;48(6):1006-1011

Authors: Huang JJ, Zhang H, Zhang W, Wang X, Gong YH, Wang GF

Abstract
OBJECTIVE: To investigate the early complication rate and identify patient-related independent clinical risk factors for early complications in patients following interventional pulmonology procedures.
METHODS: In the period from December 2014 to December 2015, sufficient data of Peking University First Hospital Respiratory and Critical Care Medicine Department for analysis were identified in 218 subjects. Interventional pulmonology procedures were performed in all the patients. Early complications after the procedures were defined as newly respiratory failure, arrhythmia requiring treatment, severe hemoptysis, pneumothorax, pneumomediastinum, pulmonary edema, tracheoesophageal fistulae, bronchopleural fistulae, acute coronary syndrome, acute cerebrovascular accident, and death. Patient-related clinical risk factors were defined as coronary atherosclerotic heart disease, cerebral infarction, diabetes mellitus, cirrhosis, chronic kidney disease, arrhythmia, asthma, chronic obstructive pulmonary disease, hypertension, and previous interventional pulmonology treatment. The patient-related independent clinical risk factors which had close relations to the occurrence of early complications were analyzed by multivariate statistical analysis with Logistic regression.
RESULTS: There were 56.4% male and 43.6% female subjects in this study. There were 10.6% current smokers, 26.6% former smokers, and 62.8% non-smokers. The overall early complication rate was 8.3%. In all the subjects groups, the patient-related independent clinical risk factors for the early complication rate were coronary atherosclerotic heart disease (B=1.545, P=0.006, OR=4.686, 95% CI 1.568-14.006), chronic obstructive pulmonary disease (B=1.037, P=0.049, OR=2.820, 95% CI 1.675-11.790), and current smoking status (B=1.412, P=0.032, OR=4.139, 95% CI 1.134-15.109); for the newly respiratory failure rates were coronary atherosclerotic heart disease (B=2.207, P=0.004, OR=9.087, 95% CI 2.028-40.714), chronic obstructive pulmonary disease (B=1.646, P=0.048, OR=5.188, 95% CI 1.783-34.375), and lesions involving three central airways (B=1.899, P=0.032, OR=6.680, 95% CI 1.182-37.740). In the malignant group, the patient-related independent clinical risk factor for the early complication rate was current smoking status (B=2.953, P=0.006, OR=19.161, 95% CI 2.360-155.572). In the benign group, the patient-related independent clinical risk factor for the early complication rate was only coronary atherosclerotic heart disease (B=1.976, P=0.022, OR=7.214, 95% CI 1.324-39.298).
CONCLUSION: Closer monitoring of patients with identified clinical risk factors is advisable prior and immediately after interventional pulmonology procedures. In order to avoid or minimize early complications, special attention should be directed toward patients who are current smokers, or patients with lesions involving three central airways, or with coronary atherosclerotic heart disease or chronic obstructive pulmonary disease.

PMID: 27987505 [PubMed – in process]

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Evaluation of New Drugs for Asthma and COPD: Endpoints, Biomarkers and Clinical Trial Design.

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Evaluation of New Drugs for Asthma and COPD: Endpoints, Biomarkers and Clinical Trial Design.

Handb Exp Pharmacol. 2016 Nov 13;

Authors: Singh D

Abstract
There remains a considerable need to develop novel therapies for patients with asthma and chronic obstructive pulmonary disease (COPD). The greatest challenge at the moment is measuring the effects of novel anti-inflammatory drugs, as these drugs often cause only small effects on lung function. Measurements that demonstrate the pharmacological and clinical effects of these drugs are needed. Furthermore, we now recognise that only subgroups of patients are likely to respond to these novel drugs, so using biomarkers to determine the clinical phenotype most suitable for such therapies is important. An endotype is a subtype of a (clinical) condition defined by a distinct pathophysiological mechanism. An endotype-driven approach may be more helpful in drug development, enabling drugs to be targeted specifically towards specific biological mechanisms rather than clinical characteristics. This requires the development of biomarkers to define endotypes and/or to measure drug effects. This newer approach should continue alongside efforts to optimise the measurement of clinical endpoints, including patient-reported outcome measurements, required by drug regulatory authorities.

PMID: 27838852 [PubMed – as supplied by publisher]

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European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): a Real-Life Clinical Assessment.

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European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): a Real-Life Clinical Assessment.

Allergy. 2016 Oct 8;:

Authors: Calderón MA, Vidal C, Rodríguez Del Río P, Just J, Pfaar O, Tabar AI, Sánchez-Machín I, Bubel P, Borja J, Eberle P, Reiber R, Bouvier M, Lepelliez A, Klimek L, Demoly P, EASSI Doctors’ Group

Abstract
BACKGROUND: Outside clinical trials, data on systemic reactions (SRs) due to allergen immunotherapy (AIT) are scarce.
METHODS: A prospective, longitudinal, web-based survey of “real-life” respiratory allergen immunotherapy (AIT) clinical practice was conducted in France, Germany and Spain. SRs were recorded and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and risk factors associated with SRs were identified.
RESULTS: A total of 4,316 patients (corresponding to 4,363 ongoing courses of AIT) were included. 109 SRs were recorded, and 90 patients (2.1%) presented at least one SR. Most of the SRs occurred in subcutaneous allergen immunotherapy (SCIT) (89%, n=97). The most frequently reported symptoms were urticaria, rhinitis, dyspnoea and cough. Respiratory symptoms appeared before skin symptoms. Most SRs occurred during the up-dosing phase (75.8%) and were mild in severity (71.6%). Intramuscular adrenaline was administered in 17 SRs but only 65% of these were subsequently classified as anaphylaxis. Independent risk factors for SRs during SCIT were: the use of natural extracts (odds ratio (OR) [95% confidence interval (CI)]=2.74 [1.61-4.87]; p=0.001), the absence of symptomatic allergy medications (1.707 [1.008-2.892], p=0.047), asthma diagnosis (1.74 [1.05-2.88], p=0.03), sensitization to animal dander (1.93 [1.21-3.09]; p=0.006) or pollen (1.16 [1.03-1.30]; p=0.012), and cluster regimens (vs. rush) (4.18 [1.21-14.37]; p=0.023). A previous episode of anaphylaxis increased the risk for anaphylaxis in SCIT (OR [95%CI]=17.35 [1.91-157.28]; p=0.01).
CONCLUSION: AIT for respiratory allergy is safe, with a low number of SRs observed in real-life clinical practice. A personalized analysis of risk factors could be used to minimize SRs. This article is protected by copyright. All rights reserved.

PMID: 27718250 [PubMed – as supplied by publisher]

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Evaluation of Tolerability and Safety of “Allergovac Poliplus” in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice

Conditions:   Allergic Rhinitis;   Rhinoconjunctivitis;   Asthma
Intervention:   Biological: Allergovac Poliplus
Sponsor:   BIAL Industrial Farmacéutica S.A.
Not yet recruiting – verified July 2016

View full post on ClinicalTrials.gov: asthma | Studies received in the last 14 days