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Read our disclaimer for details. Last Update Posted : July 28, See Contacts and Locations. Study Description. Show detailed description. Hide detailed description. Detailed Description:. FDA Resources. Outcome Measures. Exacerbation that requires treatment with oral steroid for patients on maintenance oral steroid, then increase in dose of the oral steroid.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Asthma is defined as those with a consistent history and prior documented evidence of variable airflow obstruction. Subjects on steps 4 and 5 of GINA asthma therapy Exclusion Criteria: Patients with respiratory diseases with other known respiratory diseases including chronic obstructive pulmonary disease, bronchiectasis, tuberculosis TB -destroyed lung parenchyma, history of lung resection and lung cancer Individuals older than 40 years with a smoking history of more than 10 pack-years Pregnant women.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. These guidelines aim to provide evidence based recommendations on diagnosis and management of type 2 diabetes and management of asthma and chronic obstructive pulmonary disease in primary health care in low-resource settings.
It recommends a set of basic interventions for physicians and health workers. Asthma severity assessment in clinical practice There is a trend in clinical practice to retrospectively assess asthma severity based on the step of treatment required to control symptoms and attacks.
Since asthma severity level could change over years or months, therefore, asthma level of severity can be as classified as follows: Mild asthma: Controlled asthma at step 1 or 2 Moderate asthma: Controlled asthma at step 3 Severe asthma: Asthma that requires treatment step 4 or 5.
Non-Pharmacological Management The long-term goal of asthma therapy is to achieve and maintain asthma control by utilizing pharmacological and nonpharmacological measures [ Box 5. Box 5. Developing a partnership with the patient The development of a partnership between patients and healthcare professionals leads to enhancement of knowledge, skills, and attitude that lead toward better understanding of asthma and its management.
Asthma education The goal of asthma education is to provide patients with asthma or the parents of a child with asthma adequate training to enhance their knowledge and skills to be able to adjust treatment according to guided self-management. Identify and reduce exposure to risk factors Measures to prevent or reduce exposures to risk factors should be implemented wherever possible. Measures to avoid tobacco exposure will lead to better asthma control and avoidance of long-term lung function impairment Outdoor allergens and dust: Outdoor allergens such as pollens and molds are impossible to avoid completely; exposure may be reduced by closing windows and doors and using air conditioning if possible.
It is advisable to avoid going out in the storm if possible, especially for those with uncontrolled asthma [ 98 ] Occupational exposures: Whenever an occupational sensitizer is identified, it is advisable to keep the affected person away from that environment. The earlier the removal of this sensitizer takes place, the higher the chance of complete recovery from occupational asthma Food and drugs: Food and food additives are uncommon triggers of asthma.
Pharmacological Management in Adults and Adolescent The SINA expert panel recommends asthma treatment to be based on the following phases: Initiation of treatment Adjustment of treatment Maintenance of treatment. Box 6. Initiation of treatment Patients with asthma often underestimate the presence of symptoms and tend to assume that their asthma is controlled even when this is not the case.
Adjustment of treatment After initiation of asthma treatment, it is recommended to assess the patient at 1—3-month intervals Evidence D.
Early consideration may save the patient from frequent or chronic use of oral corticosteroids Consultation with an asthma specialist is recommended for patients who require this step of therapy Evidence D. Treatment at step 5 Consultation with an asthma specialist is strongly recommended for patients requiring treatment at step 5 Evidence D To avoid frequent use of oral steroids, biologic therapy should be considered based on appropriate indications and availability Anti-IgE therapy omalizumab may be considered for those patients uncontrolled on maximum treatment at step 4 despite modification of any triggers and who have allergic asthma as determined by an IgE level in the appropriate therapeutic range, and positive skin test or RAST study Evidence A , or a history of documented atopy Evidence D.
The recommended dose is 30 mg subcutaneously every 4 weeks for the first 3 months and then every 8 weeks thereafter There is no available evidence that compares anti-IgE therapy to any of the anti-IL-5 therapies or directly comparing different anti-IL-5 agents For patients with evidence of both atopy and high blood eosinophils, to date, there is no available evidence to favor either anti-IgE therapy versus anti-IL-5 agents.
Maintaining high-dose ICS therapy may help reduce the dose of systemic corticosteroid Upward adjustment of the corticosteroid dose at the time of stress e. Maintaining asthma control Regular follow-up by a healthcare worker is essential. Referral to an asthma specialist Situations that require referral to an asthma specialist for consultation or comanagement include: Uncertainty regarding the diagnosis Difficulty achieving or maintaining asthma control Immunotherapy or biologic therapy is being considered Difficulty to achieve asthma control at step 3 or higher Acute asthma attack requiring hospitalization Request of a patient for second opinion or further advice.
Allergen immunotherapy The allergen immunotherapy AIT is a treatment modality to desensitize patients to specific allergens. Severe asthma Severe asthma carries several names; each point to an aspect of the disease. Asthma phenotyping Phenotyping plays a major role in predicting the response to treatment of severe asthma.
For patients with severe asthma that do not qualify or respond to biologic therapy, other modalities of treatment of severe asthma are recommended for consideration that includes: Macrolides: Due to their role in reducing neutrophilic airway inflammation, they were shown to have a role in the management of severe asthma. It has significantly improved asthma-related quality of life measures, and responses in eosinophilic asthma were greater than in those without eosinophils Bronchial thermoplasty BT : Utilizing radiofrequency energy to alter the smooth muscles of the airways and possibly bronchial wall innervation, BT has been shown to reduce the risk of asthma attacks in clinical trial setting.
Management of Acute Asthma in Adults and Adolescents Acute asthma attack is a challenging clinical scenario that requires a systemic approach to rapidly diagnose the condition, evaluate its severity, and initiate therapy.
Clinical assessment of acute asthma The initial clinical assessment should rapidly determine whether the patient's presenting symptoms are related to an acute asthma attack or not. Box 7. Initial management of acute asthma for adults and adolescents. Assessment of acute asthma severity Mild acute asthma: Patients presenting with mild asthma attack are usually treated in an outpatient setting by stepping up in asthma management, including increasing the dose of ICS.
CXR is not usually required for moderate asthma attacks, unless pneumonia is suspected Severe acute asthma: Patients are usually agitated and unable to complete full sentences. Chest radiograph is required if complications are clinically suspected such as pneumothorax or pneumonia Life-threatening acute asthma: Patients with life-threatening asthma are severely breathless and unable to talk.
Initial treatment of acute asthma After initial assessment of asthma attack, it is recommended to base treatment on severity level [ Box 7. Alternatively, ipratropium bromide can be administered by MDI at a dose of 4—8 puffs every 20 min and then every 4—6 h as needed [ , , , ] Systemic steroid is recommended to be started as soon as possible Evidence A.
Alternatively, the following may be prescribed: daily hydrocortisone dose of mg IV or daily methylprednisolone dose of 80 mg, in divided doses [ , ] If there is no adequate response to previous measures, it is recommended to administer a single dose of IV magnesium sulfate at a dose of 1—2 g over 20 min Evidence B [ ] Request CXR, electrolytes, glucose, lead ECG, and ABG, Life-threatening asthma Patients in this category can progress rapidly to near-fatal asthma, respiratory failure, and death.
Follow-up after initial treatment Close evaluation of treatment response is recommended that and includes patient's mental and physical status, respiratory rate, heart rate, blood pressure, oxygen saturation, and PEFR. Adjustment of acute asthma treatment for adults and adolescent. Alternatively, IV hydrocortisone mg daily or IV methylprednisolone 80 mg in divided doses Observe closely for any signs of fatigue or exhaustion Monitor oxygen saturation, serum electrolytes, ECG, and PEFR Admit to hospital if the patient fails to show adequate response.
Management Patients showing poor response after 4 h of therapy should have the following recommendations: Consider ICU admission Deliver continuous nebulization of salbutamol and ipratropium bromide, unless limited by side effects Continue systemic steroid: IV hydrocortisone mg daily or IV methylprednisolone 80 mg in divided doses. Criteria for ICU referral ICU referral is recommended for patients: Requiring ventilatory support Developing acute severe or life-threatening asthma Failing to respond to therapy, evidenced by: Deteriorating PEFR Persisting or worsening hypoxia Hypercapnia ABG analysis showing respiratory acidosis Exhaustion, shallow respiration Drowsiness, confusion, altered conscious state.
Asthma in Special Situations Cough-variant asthma Patients with cough-variant asthma have chronic cough as their main symptom. Exercise-induced bronchoconstriction Exercise-induced bronchoconstriction EIB is common in inadequately controlled asthma patients. Aspirin-exacerbated respiratory disease ASA-exacerbated respiratory disease AERD is a special phenotype characterized by a triad of asthma, chronic rhinosinusitis with nasal polyposis, and respiratory reactions to ASA.
Gastroesophageal reflux disease GERD disease is more prevalent in patients with asthma compared to the general population. Pregnancy A study conducted in a tertiary care hospital in Saudi Arabia showed that almost half of pregnant women had the desire to stop asthma medications during pregnancy as they believed that asthma medications would harm them and their babies more than asthma itself.
Occupational asthma All patients with asthma should be asked about their work history and exposures for possible related causal factors. Asthma-chronic obstructive pulmonary disease overlap COPD is common above the age of 40 years. Management of Asthma in Children Asthma represents the most common chronic illness of childhood. Asthma phenotypes in children Based on several longitudinal studies, wheezing has been categorized epidemiologically into transient and persistent wheeze phenotypes.
Asthma wheeze phenotype in children has been classified as:[ , ] Early transient wheezing before the age of 3 years with resolution by the age of 6 years Persistent wheezing that starts before the age of 3 years and continues after the age of 6 years Late-onset wheezing between 3 and 6 years of age.
Prediction of asthma in preschool children For early identification of the risk for persistent asthma among preschool children, the SINA expert panel recommends the utilization of the modified asthma predictive index modified-API.
Strategies of asthma management in children The long-term goals of asthma management in children are not different from those of adults [ Box 5. The asthma management strategy should include: Assessment of asthma control combined with proper treatment This implies a periodical assessment of asthma control combined with adjustments if needed of treatment based on the level of control.
Role of patient education Patient education is recommended to be an integral part of asthma management strategy in children. Setting asthma action plans An action plan that documents medications, doses, and device technique should be provided to patients and their caregivers. Prevention Asthma attacks can be triggered by a variety of factors including allergens, viral infection, pollutants, and drugs. Outpatient management of asthma in children Management of asthma should be adjusted continuously based on asthma control.
More details of the use of ICS in children are available in Appendix 1 There are insufficient data to recommend short courses of high-dose ICS in children with mild intermittent asthma attacks Evidence B. Reliever therapy Oral bronchodilator therapy is not recommended to be prescribed due to slower onset of action and higher side effects [ , ] LABA should not be used alone as maintenance monotherapy in children Evidence A.
Devices As inhalers are the main method of delivering medications, it is recommended to choose the appropriate device [ Box 9. Adjustment of asthma treatment in children Assessment of adherence, proper device use, control of environment, and confirmation of the diagnosis, especially if there is a failure to respond to therapy, are recommended each time before treatment adjustments.
Outpatient management of Asthma for children aged 5 to 12 years. Referral to an asthma specialist Referral to an asthma specialist for consultation or co-management is recommended in the following situations: There is uncertainty regarding the diagnosis There is difficulty achieving or maintaining control of asthma Immunotherapy or omalizumab is being considered The patient requires step 4 care or higher The patient has had an asthma attack requiring a hospitalization or 2 or more oral corticosteroids in the past 12 months.
Initial management of acute asthma at home The SINA expert panel recommends management of a child with asthma to include an action plan that enable the caregiver to recognize worsening of asthma and the advices for initial treatment Evidence D.
Assessment of asthma severity in the emergency department Assessment of acute asthma severity in children has an important role in various components of acute asthma management such as pharmacological interventions, need for hospitalization, and need for ICU admission. Box Management of acute asthma in the emergency department After performing the necessary clinical assessment, the SINA expert panel recommends the utilization of PRAM as a tool to assess patients in the ED and guide further management as well.
After initial clinical assessment and starting initial appropriate therapy, managing physician is recommended to focus on obtained history to identify risk factors for ICU admission, including:[ ] Previous life-threatening asthma attack Previous ICU admission Previous intubation Deterioration while already on systemic steroid.
Management after initial treatment based on PRAM score PRAM score is 1—3 The child may be discharged on salbutamol inhaler and ICS inhaler with a spacer If oral steroids course is given initially, dexamethasone is recommended for extra one day and prednisolone for total of 3—5 days It is recommended to offer the child an action plan, education on inhalers technique, and a follow-up visit within 1 week to the appropriate clinic.
PRAM score is 4—7: Treat as a moderate asthma attack see below. PRAM score is 8— Treat as a severe asthma attack see below. If PRAM score after 1 h is 1—3, observe for another hour. Management after initial treatment based on PRAM score: PRAM score is 1—: The child may be discharged on salbutamol inhaler with a spacer and ICS if the patient is not already on controller treatment Complete the course of oral steroids.
Dexamethasone is recommended for extra 1 day and prednisolone for total of 3—5 days; both as once daily dose It is recommended to offer the child an action plan, education on inhalers technique, and a follow-up visit within 1 week to the appropriate clinic. Management after initial treatment based on PRAM score: PRAM score is 1—3: The child may be discharged on salbutamol inhaler with a spacer and ICS if the patient is not already on controller treatment Complete the course of oral steroids.
It is recommended to: Establish IV access and to start on appropriate IV fluids Continue nebulized salbutamol back-to-back every 20 min or use continuous salbutamol nebulization at a dose of 7. Appendix 1: Medications Used for the Treatment of Asthma The objective of asthma treatment is to achieve and maintain control of the disease. Controller medications Inhaled corticosteroids ICSs are currently the most effective anti-inflammatory medications for the treatment of asthma.
Aerosol devices used in asthma Medication aerosol can be delivered using three devices: Small-volume nebulizer It is the most popular for patients and clinicians in acute asthma. Pressurized metered-dose inhaler It is a pre-pressurized inhaler with medication and a propellant, which when actuated will give one dose of the drug for a single inspiration.
Breath-actuated inhalers These inhalers automatically release a spray of medication when the person begins to inhale. Biologics in asthma treatment The recent progress in biologic therapy in asthma has made a step forward toward the practice of precision medicine for asthma patients. Anti-immunoglobulin E Omalizumab is a recombinant humanized monoclonal antibody against soluble IgE. Anti-interleukin 5 IL-5 is critical for the development and maturation of eosinophils.
There are currently three different anti-IL5 medications in clinical use: Mepolizumab binds circulating IL5. It is given as mg monthly subcutaneously by injections Reslizumab binds circulating IL5. Potential future biologic therapies There are different biologic agents under development that target the inflammatory pathway. Disclaimer These guidelines for the diagnosis and management of asthma in adults and children, developed by the SINA panel, are not meant to replace clinical judgments of physicians but to be used as tools to help the practicing physicians to manage asthma patients.
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