asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: BREVA
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: SALBUTAMOLO
CAS Number: 18559-94-9
Concentration unit: µg microgram(s)
Concentration type: equal
Concentrat
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 6 to 12 years old children with asthma and gastroesophageal reflux Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Other chronic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Verify if the Ipratropio bromuro-albuterol association improve PEFR (FEV1, FVC e FEV1/FVC).;Secondary Objective: To evaluate if the association of Ipratropium Bromide and Albuterol is more effective than Albuterol to improve pulmonary function tests and asthma symptoms control.;Primary end point(s): Verify if the Ipratropio bromuro-albuterol association improve PEFR (FEV1, FVC e FEV1/FVC). | — |
Countries
Italy
Outcome results
None listed