Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Formoterol Fumarate

Criteria

Inclusion Criteria:

Healthy volunteers:

• Males and females aged 18-65 years;

• Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;

• Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year;

• Normal blood pressure and heart rate;

• Normal electrocardiogram (ECG,12 lead);

• Normal laboratory tests;

Patients with Asthma:

• Males and females aged 21-65 years;

• BMI between 18.0 and 28.0 kg/m2;

• Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year;

• Normal blood pressure and heart rate;

• Normal ECG (12 lead);

• FEV1 ≥ 30% and < 80% of predicted according to European Coal and Steel Community values (ECSC)

• Reversibility of FEV1 ≥ 12% and at least 200 ml of the initial value 15 minutes after inhalation of 200 µg Salbutamol;

Patients with COPD:

• Males and females aged 40 - 70 years

• BMI between 18.0 and 30.0 kg/m2;

• Normal blood pressure and heart rate;

• Normal ECG (12 lead);

• Stable COPD within the past 4 weeks;

• Post bronchodilator FEV1 between 30% and 50% predicted values (ECSC);

• Post bronchodilator FEV1/FVC < 0.70 (absolute value);

• Minimum smoking history of 10 pack-years;

Exclusion Criteria:

All subjects:

• Blood donation or blood loss in the previous 8 weeks;

• Positive HIV1 or HIV2 serology;

• Positive acute or chronic Hepatitis B or Hepatitis C;

• Unsuitable veins for repeated venipuncture;

• Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception.

• History of substance abuse or positive urine drug screen;

• Abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;

• Uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric clinically significant disorder;

• Participation in another clinical trial in the previous 8 weeks; participation in study using radioactive material within 1 calendar year;

• Known sensitivity to Formoterol or Beclometasone or any of the excipients;

• Concomitant severe diseases or diseases which are contra indications for the use of inhaled Beta-2-agonist or steroids;

• Use of any prescription drug for which concomitant beta-agonist or steroid administration are contraindicated;

• Recent relevant infectious disease (less than two months);

• Flu vaccination or other vaccination within 4 weeks prior to the screening visit;

Additional exclusion criteria for healthy volunteers:

• Lung function measurements outside normal limits (normal values: FEV1/FVC > 0.70 and FEV1 and FVC > 80% for the ECSC predicted values);

Additional exclusion criteria for patients with Asthma:

• Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;

• Life-threatening/unstable respiratory status within the previous 30 days;

• Requirement of supplemental oxygen therapy;

• Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit;

• Asthma exacerbation within the 4 weeks prior to inclusion.

Additional exclusion criteria for patients with COPD:

• Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;

• Life-threatening/unstable respiratory status within the previous 30 days;

• Requirement of supplemental oxygen therapy;

• Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit;

• COPD exacerbation within the 4 weeks prior to inclusion;

• History of asthma or any chronic respiratory diseases other than COPD.