Status:
COMPLETED
Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Pulmonary Disease, Chronic Obstructive
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 99mT...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01176747
Start Date
August 1 2010
End Date
October 1 2010
Last Update
October 29 2021
Active Locations (1)
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1
Inamed Research GmbH & Co. KG
Gauting, Germany, 82131