In-vivo deposition of formoterol after inhalation of a single dose of Formoterol HFA- MDI (Chiesi), and Foradil P inhalation powder (Novartis) in COPD patients.

• Conditions: The study is focused on chronic obstructive pulmonary disease (COPD)

• Registration Number: EUCTR2005-003693-14-DE
• Lead Sponsor: Chiesi farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-11
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

•Age 40 - 70
•Ability to properly use the MDI and DPI
•Body weight resulting in a Body Mass Index (BMI) between 18.0 and 35 kg/m2
•Normal blood pressure and heart rate (supine SBP 100-140 mmHg, supine DBP 45-90 mmHg, heart rate 45-90 bpm). Minor deviations are acceptable provided that they are not judged relevant by the clinical investigator
•Electrocardiogram (12 lead) with computerized protocol interpretation considered as normal (120ms ?PR? 220ms, QRS ?120ms, QTc ?450ms (male), ? 470 ms (female)). Minor deviations are acceptable provided that they are not judged relevant by the clinical investigator
•Primary diagnosis of COPD (Diagnosis can be made during the screening process)
•Moderate COPD (FEV1/FVC = 70 %, Stage III GOLD classification) documented at screening visit
•Reversibility of FEV1 < 12 % of the initial value after inhalation of 200µg Salbutamol within the screening period
• Treatment with inhaled ß2-agonists at a constant dosage during the last 4 weeks prior to inclusion
•In good health on the basis of a medical history, physical examination, clinical laboratory studies and ECG, with the exception of COPD
•Minimum smoking history of 10 pack-years (pack-years = the number of cigarette per day/ 20 x number of years)
•Understanding of the study and agreement to give written informed consent before the first selection procedure.

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

•Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before the first intake of study drug
•Positive HIV1 or HIV2 serology
•Positive results from the Hepatitis serology which indicates 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 (according to CPMP/ICH 286/95 note 3 ). Postmenopausal women < 1 year must have efficient contraception
•History of substance abuse or drug abuse within 12 months or with a positive urine drug screen
•Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation
•Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
•Participation in an investigational drug study within 30 days prior to Visit 1 or current participation in another investigational drug study
•Known sensitivity to Formoterol, Salmeterol or Albuterol or any of the excipients contained in any of these formulations
•Concomitant severe diseases or diseases which are contra indications for the use of inhaled ?2-agonist
•Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation
•Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months
•History of significant sensitivity or allergy to ?2-agonists or related drugs
•Recent relevant infectious disease (less than two months)
•Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days
•Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen may not exceed 2l/min, at night time only and/or only during exercise is allowed
•Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit
•Use of any prescription drug for which concomitant beta-agonist administration is contraindicated
•Exacerbation within the 4 weeks prior to inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to assess intrapulmonary deposition of two Formoterol formulations (FORAIR, Foradil P) in patients with COPD. ;Secondary Objective: Secondary objective is to describe pharmacokinetic properties of both drug formulations. ;Primary end point(s): •Intrapulmonary deposition (DL)