Register Schweres Asthma - German Asthma Net e.V.
ConditionSevere Asthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorGerman Asthma Net e.V.
About this trial
The German Asthma Net e.V. focusses on science and research in patients with severe asthma. This includes, in particular, the optimization of medical care and treatment for patients with severe asthma as well as the elucidation and information. An unavoidable basis for a better understanding of severe asthma is the registration and comprehensive characterization of a large patient population. To date, there are only few reliable data on incidence, prevalence, phenotypes and treatment of patients with severe asthma. For this reason, the German Asthma Net e.V. was established in December 2011 as a clinical registry for patients with severe asthma, initially set up on a national basis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Maintenance treatment with high doses of ICS (>400 μg budesonide or equivalent / ≥ 200 μg of fluticasone as monotherapy) or
Maintenance treatment with medium to high doses of ICS (≥400 μg budesonide or equivalent / ≥ 200 μg fluticasone) combined with LABA and/or LTRA and/or theophylline or
Disqualifiers
Maintenance treatment with high-dose inhaled corticosteroids (≥ 1000 μg beclomethasone (BDP, powder) or equivalent) in combination with LABA or LTRA or theophylline or
Maintenance treatment with oral corticosteroids (OCS) for ≥3 months independent of other asthma treatments or
Treatment with monoclonal antibodies independent of other asthma treatments
Maintenance treatment with medium to high doses of ICS (≥ 500 μg BDP (powder) or equivalent) in combination with LABA or LTRA or theophylline and
Trial population
Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Symptom Control
Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).
Time frame
Baseline, four months, yearly for up to 15 yearsSecondary outcomes
1
Exacerbations
Number of exacerbation with/without hospitalization
Time frame
Baseline, four months, yearly for up to 15 years2
Utilization of the health care system
Number of visits at a pneumologist/ specialist, number of emergency consultations, number of hospitalizations, number of rehabilitation stays
Time frame
Baseline, yearly for up to 15 years3
Symptoms and health-related quality of life
Asthma Control Test (ACT: 5 questions, scale 1- 5, min score 5, max score 25, the lower the score the better the Asthma control)
Time frame
Baseline, yearly for up to 15 years4
Quality of Life Questionnaire
Mini Asthma Quality of Life Questionnaire (Mini-AQLQ: 15 questions, scale 1 to 7, min score 15, max score 105, the higher the score, the better the quality of life)
Time frame
Baseline, yearly for up to 15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
German Asthma Net e.V.
Lead sponsor
AstraZeneca
Collaborator
GlaxoSmithKline
Collaborator
Sanofi
Collaborator
Chiesi Farmaceutici S.p.A.
Collaborator
Source ClinicalTrials.gov