bronchiectasis. MedDRA version: 9.1 Level: LLT Classification code 10006445 Term: Bronchiectasis
Conditions
Interventions
Trade Name: flixotide
Product Name: FLUTICASONE
Pharmaceutical Form: Inhalation powder
Concentration unit: Ci/µg curie(s)/microgram
Concentration type: equal
Concentration number: 500-
Trade Name: s
Sponsors
Royal Brompton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have a clinical diagnosis of Bronchiectasis confirmed by prior CT scan 2. Have an idiopathic or post infective aetiology. All patients followed up in our clinic have undergone a protocol of investigation to determine aetiology. (Wilson 1995) 3. Be in a stable state defined as: -no oral antibiotic 6 weeks -no Intravenous antibiotics for 12 weeks -constant symptoms 4. Be aged between 18 and 75years 5. Alveolar Nitric Oxide (Calv) >1.5 6. Be willing and able to comply with study procedures and provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Bronchiectasis due to any other aetiology e.g. immunodeficiency, primary cilia dyskinesia, allergic bronchopulmonary aspergillosis (ABPA) or cystic fibrosis. 2. Oral steroids 3. Frequent exacerbations >5 in 12 months 4. Long Term Oxygen Therapy 5. Asthma by clinical criteria. 6. Methicillin Resistant Staphylococcus Aureus (MRSA) 7. Inability to comply with protocol requirements. 8. Scheduled inpatient surgery or hospitalization during course of the study. 9. Pregnant or likely to get pregnant during course of the study. 10. Participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What are the effects of salmeterol and fluticasone on alveolar nitric oxide in patients with bronchiectasis.;Secondary Objective: To discover if taking the combination of salmeterl and fluticasone or either drug lowers the level of alveolar nitric oxide in patients with bronchiectasis in whom it is elevated.;Primary end point(s): Patients may be discontinued from the study at any time, at the discretion of the investigator. Specific reasons for discontinuing a patient from this study are: 1. Voluntary discontinuation by the patient, who is at any time free to discontinue participation in the study without prejudice to further treatment. 2. Safety reasons as judged by the investigator. 3. Incorrect enrolment (i.e. the patient does not meet the required inclusion/exclusion criteria.) 4. Patient lost to follow up. | — |
Countries
United Kingdom
Outcome results
None listed