Asthma
Conditions
Interventions
Trade Name: Seretide
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Fluticasonpropionat
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
INN or Pro
Sponsors
Respiratory and Allergy Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Elite athletes (not control subjects). - Age >/= 16 years, =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - ICS within the last 4 weeks prior to visit 1. - Respiratory tract infections within the last 2 weeks prior to visit 1. - Pregnancy, breast feeding or planning pregnancy during the study. - FEV1 < 1.5 L or FEV1 < 70 % of predicted. - Subjects with a lung disease other than asthma. - Smokers or ex-smokers with a smoking history of 10 pack years or more.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To investigate the change in inflammation in EVH-positive elite athletes treated with inhaled steroids in combination with long-acting beta-agonists (ICS/LABA) compared with placebo. 2. To investigate inflammatory differences in the airways of elite athletes with a positive eucapnic voluntary hyperventilation test (EVH) and control subjects with asthma.;Secondary Objective: 1. To investigate whether the bronchial response to EVH in elite athletes is associated with the inflammatory condition. 2. To investigate the effect of treatment on symptom score and lung function in EVH-positive elite athletes.;Primary end point(s): Reduced inflammation assessed by exhaled Nitric Oxide. | — |
Countries
Denmark
Outcome results
None listed