Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)

Inclusion criteria

• Male and female patients 18-50 years of age, who have signed an informed consent form.
• Clinical evidence of asthma
• Steroid naïve asthmatic patients
• FEV1 at Screening Visit is >70 % of the predicted value and at least 2.0 L.
• Body Mass Index between 18 and 35.
• Sensitivity to AMP at Screening Visit.
• FENO levels >25 ppb at the Screening Visit

Exclusion criteria

• Having received an investigational product within 2 months of Screening Visit.
• Inability to comply with study procedures or with study treatment intake.
• Any significant lung disease which is considered by the investigator to be clinically significant.
• Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD)
• Previous or current smokers who have a smoking history greater than 5 pack years.
• Patients with any uncontrolled disease that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study.
• Patients with QTc >450msec at the Screening Visit.
• Patients with serum potassium <3.5 mEq/L or >6 mEq/L.
• Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
• Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
• Patients who have undergone major surgery in the previous 3 months.
• Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit.
• Patients treated with slow-release corticosteroids 2 months prior to Screening Visit.
• Patients currently treated with anti-IgE Antibodies.
• Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit.
• Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD).
• Females who are pregnant, lactating or planning to become pregnant