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Raissy H.H.,University of New Mexico | Blake K.,Center for Clinical Pharmacogenomics and Translational Research
Pediatric, Allergy, Immunology, and Pulmonology | Year: 2013

Asthma is characterized by inflammation of proximal and distal airways. As new formulations of extrafine aerosol particles have become available, targeting small airways for the management of asthma has been investigated. As new studies attempt to explore the correlation between small airway dysfunction and clinical outcomes in asthma, well-designed clinical trials are needed to compare targeted and standard therapy for asthma management especially in pediatric patients. © 2013 Mary Ann Liebert, Inc.


Blake K.,Center for Clinical Pharmacogenomics and Translational Research | Raissy H.,University of New Mexico
Pediatric, Allergy, Immunology, and Pulmonology | Year: 2012

Empiric use of proton pump inhibitors (PPI) for the treatment of poorly controlled asthma has increased substantially in the past decade under the presumption that gastroesophageal reflux is precipitating symptoms. No PPI has a Food and Drug Administration (FDA) approved indication for the treatment of asthma symptoms. Use has been driven by data indicating that up to 80% of children and adults with asthma have reflux by pH probe monitoring and that nearly half of patients lack typical reflux symptoms. Data from controlled studies of adults have shown only a minimal improvement in peak expiratory flow with PPI use in the overall population, with only a slightly larger improvement in patients with diagnosed gastroesophageal reflux disease, and no effect on asthma exacerbation rate in one study. The single largest placebo-controlled study in children with poorly controlled asthma without gastroesophageal reflux symptoms found no improvement in any indices of asthma control, even in children with gastroesophageal reflux by pH probe test. In children, there is a disturbing increased risk for respiratory tract infections and potentially for activity related fractures with PPI treatment. These effects are consistent with known adverse effects of PPIs. Thus use of PPI should be confined to children with asthma who also have overt symptoms of gastroesophageal reflux. PPI are unlikely to improve poorly controlled asthma. © 2012 Mary Ann Liebert, Inc.


Blake K.,Center for Clinical Pharmacogenomics and Translational Research | Raissy H.,University of New Mexico
Pediatric, Allergy, Immunology, and Pulmonology | Year: 2014

A new product, Epinephrine HFA, is being considered by the Food and Drug Administration (FDA) for marketing approval as a nonprescription bronchodilator inhaler for the treatment of the "temporary relief of mild symptoms of intermittent asthma in adults and children 12 years of age and older." This product would serve as a replacement for Primatene®Mist, which was removed from the market in December 2011 in accordance with the requirements of the Montreal Protocol to phase out chlorofluorocarbon (CFC) propellants. The Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee met in early 2014 to review the clinical data. The data indicate that Epinephrine HFA provides improvement in lung function at the proposed doses and that no clinically important safety issues were observed. There were, however, concerns that the device could malfunction and that the dose-counter could lose accuracy. These device issues are significant for a drug that could be used for life-threatening symptoms of asthma. All study data presented are publically available from the FDA website at www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/ucm380890.htm for the February 24, 2014, meeting. © 2014, Mary Ann Liebert, Inc.


Blake K.,Center for Clinical Pharmacogenomics and Translational Research | Raissy H.,University of New Mexico
Pediatric, Allergy, Immunology, and Pulmonology | Year: 2014

Data from the New Drug Application for inhaled dry powder mannitol (DPM) use in cystic fibrosis in children and adults ages 6 years and older was reviewed and discussed at the Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee meeting in January 2013. Of the two pivotal Phase III trials (CF-301 and CF-302), only one demonstrated efficacy for the primary endpoint - absolute change from baseline Forced Expiratory Volume in 1 second (FEV1 mL). In addition, neither trial demonstrated efficacy in the pediatric population who comprised 43% of the intent-to-treat study population. Also, there was an increased risk of hemoptysis in children receiving DPM versus control, and the difference in rates between DPM and control was larger than that observed in adults. This review will describe the main issues discussed for the pediatric population. All study data presented in this review are publically available from the Food and Drug Administration (FDA) Web site at www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ Pulmonary-AllergyDrugsAdvisoryCommittee/ucm329187.htm for the January 30, 2013 meeting. © Copyright 2014, Mary Ann Liebert, Inc. 2014.


Blake K.,Center for Clinical Pharmacogenomics and Translational Research | Raissy H.,University of New Mexico
Pediatric, Allergy, Immunology, and Pulmonology | Year: 2013

Asthma is difficult to diagnose in the child with sickle cell disease because symptoms and pulmonary function abnormalities are similar to the spectrum of pulmonary manifestations in sickle cell disease. There are no published reports of controlled trials of asthma medications in children with sickle cell disease. Thus, treatment decisions should be guided by the Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf). However, issues specific to children with sickle cell disease should be considered. Initial strategies should focus on control of environmental triggers, as effectiveness on asthma outcomes is proven and the cost for implementation can be low. Use of short-and long-acting β2-agonists may prolong QTc, particularly in this population of children who already have a higher prevalence of prolonged QTc than the general population. Long-acting β2-agonist use has been associated with life-threatening asthma exacerbations with potentially higher risks in African Americans. Montelukast has been reported to increase suicidal thinking and behavior, and persons with asthma and sickle cell disease are already at risk for these events. Oral corticosteroids in the treatment of acute chest syndrome may increase risk of readmission even in children with asthma. The lack of prospective controlled trials of asthma drug treatment in children with asthma and sickle cell disease compels us to move this issue forward. © 2013, Mary Ann Liebert, Inc.

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