Patients with severe asthma and persistent airflow limitation
Conditions
Interventions
Product Name: Magnesium sulfate 6,4 % solution for nebulisation
Pharmaceutical Form: Nebuliser liquid*
CAS Number: 7487889
Other descriptive name: MAGNESIUM SULFATE
Concentration unit: % (W/V) percent
Sponsors
Medical Centre Leeuwarden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Severe asthma according to ATS Criteria (See table 1) Adults between the age of 18-70 years Non smoking (maximal 10 pack-years in history) FEV1 post salbutamol (400 µg) and ipratropiumbromide (80µg) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exacerbation < 4 weeks prior to study Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the effect of nebulised isotonic magnesium sulfate on airway obstruction in stable patients with severe asthma and persistent airflow limitation.;Secondary Objective: To test the effect of nebulised isotonic magnesiumsulphate on airway inflammation in stable patients with severe asthma and persistent airflow limitation;Primary end point(s): The main study parameter is de percent change in FEV1 from postbronchodilator baseline value to endpoint (30 min after last inhalation with magnesium or placebo) The secondary study parameter is de percent change in level of NO in exhaled air from postbronchodilator baseline value to endpoint (30 min after last inhalation with magnesium or placebo) | — |
Countries
Netherlands
Outcome results
None listed