German SocietiesPulmonology2026advanced

[Use of Omalizumab-biosimilars for CRSwNP in the German Health Care System - a Position Paper of the German Societies for Allergy AeDA and ORL DGHNO-KHC].

Published by Global Initiative for Asthma · Evidence levels A, B, C, D

739References

Summary

AI-generated

The GINA 2019 update provides global evidence-based recommendations for the diagnosis, assessment, and management of asthma. A major update is the recommendation against short-acting beta2-agonist (SABA)-only treatment for adults and adolescents, instead recommending inhaled corticosteroid (ICS)-containing controllers to reduce the risk of severe exacerbations. The guideline also details stepwise management, management of severe asthma, pediatric asthma, and asthma-COPD overlap.

AsthmaGINAGlobal Initiative for AsthmaPulmonologyInhaled corticosteroidsFormoterolDupilumabSABA

Key Takeaways

1
SABA-only treatment is no longer recommended for the treatment of asthma in adults and adolescents.
2
All adults and adolescents with asthma should receive either symptom-driven or daily inhaled corticosteroid (ICS)-containing controller treatment to reduce the risk of severe exacerbations.
3
For mild asthma, preferred treatment is low dose ICS-formoterol taken as needed for symptom relief.
4
Tiotropium is approved as an add-on therapy for children ages 6 years and older.
5
Dupilumab (anti-IL4 receptor α) is recommended for patients ≥12 years with severe Type 2 asthma or OCS-dependent asthma.
6
Maintenance oral corticosteroids (OCS) are no longer a preferred treatment in Step 5 due to the high risk of adverse outcomes.
7
Difficult-to-treat asthma must be distinguished from severe asthma by checking adherence, inhaler technique, and managing comorbidities before stepping up to biologic therapies.

What's New in This Version

Key changes in 2019 include the fundamental shift to no longer recommend SABA-only treatment in adults and adolescents, recommending instead as-needed low dose ICS-formoterol or daily ICS. Tiotropium is now approved for ages 6+. Dupilumab is added for severe Type 2 asthma. High dose ICS-LABA is restricted to Step 5. Substantial revisions were made to the assessment and management pathways for difficult-to-treat and severe asthma.

Key Recommendations

Part B. Medications and strategies for symptom control and risk reduction

REC-1
SABA-only treatment is no longer recommended for treatment of asthma in adults and adolescents.
StrongEvidence: ATreatment

Step 1 Initial Treatment

REC-2
For patients with infrequent asthma symptoms (e.g. less than twice a month), as-needed low dose ICS-formoterol is the preferred initial controller treatment.
PreferredEvidence: BTreatment

Step 2 Initial Treatment

REC-3
For patients with asthma symptoms or need for reliever twice a month or more, daily low dose ICS with as-needed SABA, or as-needed low dose ICS-formoterol are preferred controller options.
PreferredEvidence: ATreatment

Step 3 Initial Treatment

REC-4
For patients with troublesome asthma symptoms most days or waking due to asthma once a week or more, low dose ICS-LABA as maintenance and reliever therapy (with ICS-formoterol) or conventional maintenance with as-needed SABA is preferred.
PreferredEvidence: ATreatment

Step 4 Initial Treatment

REC-5
Low dose ICS-formoterol as maintenance and reliever therapy, or medium dose ICS-LABA maintenance plus as-needed SABA are the preferred options.
PreferredEvidence: ATreatment

Step 5 Treatment

REC-6
Refer for phenotypic assessment and consideration of add-on treatment, such as add-on tiotropium, azithromycin, or biologic Type 2 targeted treatments (e.g., anti-IgE, anti-IL5/5R, anti-IL4R).
PreferredEvidence: ATreatment

Non-pharmacological strategies

REC-7
At every visit, strongly encourage people with asthma who smoke to quit and provide access to counseling and smoking cessation programs.
StrongEvidence: ALifestyle/Behavioral

Scope & Objectives

Clinical Topic

Asthma

Objectives

To provide an evidence-based asthma management strategy for the use of health professionals and policy-makers.

Target Patient Population

Adults, adolescents, and children with asthma.

Diagnostic Criteria

History of respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough that vary over time and in intensity, together with variable expiratory airflow limitation.

Target Providers

Health professionalsPolicy-makersPrimary care providersPulmonologistsPediatricians

Patient Criteria & Setting

Therapeutic Area

Respiratory

Guideline Scope

DiagnosisManagementPreventionAssessment

Care Settings

Primary careEmergency departmentHospitalSpecialist clinics

Special Populations

Children 5 years and youngerPregnant womenOlder adultsSmokers and ex-smokersObese patientsOccupational asthma

Evidence Grading

System: Evidence levels A, B, C, D

Evidence Levels

ARandomized controlled trials (RCTs) and meta-analyses. Rich body of data. Evidence is from endpoints of well designed RCTs, meta-analyses of relevant studies, or strong observational evidence.

BRandomized controlled trials (RCTs) and meta-analyses. Limited body of data. Evidence is from endpoints of intervention studies that include only a limited number of patients, post hoc or subgroup analysis of RCTs.

CNonrandomized trials. Observational studies. Evidence is from outcomes of uncontrolled or non-randomized trials or from observational studies.

DPanel consensus judgment. Used only in cases where guidance was deemed valuable but the clinical literature addressing the subject was insufficient to justify placement in other categories.

Safety & Contraindications

Contraindications

Aspirin and NSAIDs in patients with a history of previous reactions
Non-selective beta-blockers without specialist supervision

Monitoring Guidance

Assess symptom control, exacerbation risk factors, and inhaler technique at every visit. Review response 2-3 months after initiating treatment, and periodically thereafter. Step down treatment once good control is maintained for 3 months.

Authors & Contributors

Helen K ReddelLouis-Philippe Boulet

Guideline Features

Dosing informationFlowcharts includedBased on systematic reviewMultidisciplinaryPatient involvementDrug interactions discussed

Learning Context

Difficulty

advanced

Exam Relevance

Stepwise asthma management algorithmsAsthma vs COPD syndromic diagnosisSevere asthma biologic criteriaAsthma exacerbation severity and managementPediatric asthma diagnosis

Learning Paths

Asthma DiagnosisStepwise ManagementSpirometryExacerbation ManagementSevere Asthma PhenotypingAsthma-COPD Overlap (ACO)Inhaler TechniqueBiologic Therapies