Mild Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: FOSTER
Product Name: Foster
Product Code: CHF 1535 HFA pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: FORMOTEROL FUMARATE
CAS Number: 43229-80-7
Other desc
Sponsors
Chiesi Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients 18-50 years of age, who have signed an informed consent form. 2. Clinical evidence of asthma, associated with one of the following: a) Demonstration of =12% reversibility and 200-mL improvement of FEV1 using a standard dose of salbutamol (up to 400µg) within 30 minutes. b) Historical bronchial hyper-reactivity to (=8 mg/mL) methacholine 3. Steroid naïve asthmatic patients 4. Patients whose FEV1 at Screening Visit is >70 % of the predicted value (after appropriate wash-out from bronchodilators) and at least 2.0 L. 5. Body Mass Index between 18 and 35. 6. Sensitivity to AMP causing a 20% drop in FEV1 (PC20 = 20 mg/ml) at the Screening Visit 7. FENO levels >25 ppb at the Screening Visit 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Having received an investigational product within 2 months of Screening Visit. 2. Inability to comply with study procedures or with study treatment intake. 3. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered by the investigator to be clinically significant. 4. Patients who suffer from COPD as diagnosed by the GOLD guidelines (2006). 5. Previous or current smokers who have a smoking history greater than 5 pack years, (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked). 6. Patients with an uncontrolled cardiovascular, respiratory, haematologic, immunologic, renal, neurologic, hepatic, endocrine disease, or any condition that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study. 7. Patients with QTc >450msec at the Screening Visit. 8. Patients with serum potassium 6 mEq/L. 9. Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids. 10. Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance. 11. Patients who have undergone major surgery in the previous 3 months. 12. Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit. 13. Patients treated with slow-release corticosteroids 2 months prior to Screening Visit. 14. Patients currently treated with anti-IgE Antibodies. 15. Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit. 16. Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD). 17. Females who are pregnant, lactating or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if FEV1 measurements, fractional exhaled nitric oxide (FENO) and PC20 after AMP challenge, after administration of a fixed combination of a LABA and an ICS at increasing doses, may be suitable to demonstrate a dose response;Secondary Objective: Not applicable;Primary end point(s): • AUC(0-4h) FEV1 measured on Day 1 of each 3-day study period • FENO levels will be measured at 4h post the 5th dose on Day 3 of each study period immediately before the AMP challenge using standard technique. • PC20 AMP at 4h post the 5th dose on Day 3 of each study period immediately after the exhaled FENO measurement. | — |
Countries
United Kingdom
Outcome results
None listed