Moderate severe bronchial asthma
Conditions
Interventions
Product Name: Flutide® 250 Diskus®
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Fluticasone propionate
CAS Number: 80474-14-2
Concentration unit: µg microgram(s)
Concentr
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and/or female moderate to severe asthmatic patients, from 18-75 years of age. 2. Diagnosis of Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months. No concomitant lung disease or significant medical conditions that would affect the subjects’ safety from participating in the study, or that would be expected to impact on the result from the study. 3. Fluticasone propionate 500mcg daily or greater, or equivalent (Mometasone 800 mcg, triamcinolone 2000 mcg, Flunisolide 2000 mcg, Budesonide DPI 800 mcg, Beclomathasone HFA 500 mcg, Beclomethasone CFC 1000 mcg) 4. FEV1 at screening will be = 70% of the normal predicted FEV1. 5. Evidence of asthma, demonstrated by one of the following: Historical evidence confirmed by their treating physician. or Demonstration of = 12% reversibility of FEV1 using a standard dose of salbutamol (up to 400 µg) within 30 minutes. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 h during which no short-acting ß2-agonist has been inhaled, or longer as required for long-acting ß2-agonist. or Documented bronchial hyper-reactivity to (=8 mg/mL) metacholine or histamine challenge. 6. Female subjects of child bearing potential must be using two forms of contraception, either double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom, or the contraceptive pill plus condom. or: Postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion. Menopause will be confirmed by laboratory tests. 7. Body Mass Index between 18 and 30. Body weight should be less than 100 kg. 8. Able to provide written informed consent prior to study participation. 9. Able to communicate well with the investigator and comply with the requirements of the study. 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. Smokers with a history of tobacco use greater than 10 pack years (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports cigarette use. 2. Concomitant medications: • Except for short acting ß2-agonists for symptom relief and long acting ß-agonists (in case this was part of patients usually prescribed medication) medication associated with study procedures and medication which may be required to treat adverse events, all other medications, other than study drug should be avoided from screening until all of the study completion evaluations have been conducted. Paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF. A washout period of 3 months is required for previous administration of any biologic therapy. The following wash-out periods should be adhered to for asthma treatments: • Increase in Inhaled steroid use: 6 weeks before study start and during study. • Oral steroids: 8 weeks before study and during study. • Topical steroids: 4 weeks before study and during study (of if not possible, dose should remain constant for the two weeks before and during the study). • Antileukotrienes: 4 weeks before study start and during study. • Antihistamines/cromoglycates: 4 weeks and during study. • Theophyllin: 4 weeks before and during study. 3. Medical conditions: • history of clinically significant drug allergy; • any significant medical condition that in the opinion of the Investigator may compromise subject safety, subject compliance, interfere with evaluations, or preclude completion of the trial. For example, a history of any pulmonary disorder other than asthma. 4. Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of the drug. 5. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. 6. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation. 7. Significant illness within the two weeks prior to dosing. 8. A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome. 9. History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia). 10. A known hypersensitivity to Fluticasone propionate or drugs similar to Fluticasone propionate. 11. History of immunocompromise, including a positive HIV test result. 12. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. 13. History of drug or alcohol abuse within the 12 months prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the change in inflammatory parameters in response to a decrease in inhaled ICS compared to no change in therapy after 2 and 4 weeks;Secondary Objective: • To identify which parameter/combination of parameters is most sensitive to the steroid reduction • To provide sufficient data to assess sample size calculations for subsequent studies;Primary end point(s): FEV1 is measured at screening (Visit 1), Baseline (Visit 2), Visit 3 and Study Completion (Visit 4). Peak Expiratory Flow Rate (PEF): Morning PEF will be measured daily during the whole study period. Exhaled nitric oxide [ppb] will be assessed by using the Nioxx - analyzer (Aerocrine, Sweden) at a flow rate of 50 ml/sec. This measurement will be performed Visits 2, 3 & 4. Bronchial Hyperreactivity (PC20) Differential cell counts in blood samples (eosinophils) and sputum (see protocol for details) | — |
Countries
Germany
Outcome results
None listed