In-vivo deposition measurement of formoterol and beclomethasone after inhalation of a single dose of the combination Formoterol plus BDP HFA pMDI (Foster®, Chiesi) in healthy volunteers, asthmatic and COPD patients

• Conditions: The study is focused on asthma bronchiale and chronic obstructive pulmonary disease (COPD); MedDRA version: 8.1Level: PTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2006-005557-30-DE
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Healthy subjects:
1.Age 21 - 70
2.Ability to properly use the pMDI
3.Body Mass Index (BMI) between 18.0 and 30 kg/m2
4.Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
DBP 50-90 mmHg, heart rate 50-90 bpm)
5.Electrocardiogram (12 lead) with computerized protocol interpretation
considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms).
6.Non-smokers or ex-smokers with a smoking history of less than 5 pack-
years and stopped smoking at least one year ago.
7.written informed consent

Patients with Asthma:
1.Age 21 - 70
2.Ability to properly use the pMDI
3.Body Mass Index (BMI) between 18.0 and 30 kg/m2
4.Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
DBP 50-90 mmHg, heart rate 50-90 bpm).
5.Electrocardiogram (12 lead) with computerized protocol interpretation
considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms).
6.Patients with moderate persistent or severe persistent Asthma according
to the GINA Classification of Asthma Severity by Daily Medication Regimen
and Response to Treatment.
7.FEV1 = 30% and < 80% of predicted for the patient’s normal value
(according to the predicted value for spirometric function, European Coal
and Steel Community values) measured at least 8 hours after the last
use of short-acting ß2-agonist bronchodilators or short-acting
anticholinergics, 72 hours after the last use of long-acting ß2- agonist
bronchodilators and 72 hours after the last use of long-acting
anticholinergics.
8.Reversibility of FEV1 = 12% and at least 200 ml of the initial value 30
minutes after inhalation of 200 mcg Salbutamol within the screening period
9.In good health on the basis of a medical history, physical examination,
clinical laboratory studies and ECG with the exception of Asthma
10.Non-smokers or ex-smokers with a smoking history of less than 5 pack-
years (e.g. < 20 cigarettes per day for 5 years or 40 cigarettes per day for
2.5 years) and stopped smoking at least 1 year ago.
11.written informed consent

Patients with COPD:
1.Age 40 - 70
2.Ability to properly use the pMDI
3.Body weight resulting in a Body Mass Index (BMI) between 18.0 and 30
kg/m2
4.Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
DBP 50- 90 mmHg, heart rate 50-90 bpm).
5.Electrocardiogram (12 lead) with computerized protocol interpretation
considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms).
6.Stable COPD
7.Decreased FEV1 between 30% and 50% predicted values (30% =FEV1 <
50%) measured at least 8 hours after the last use of short-acting ß2-
agonist bronchodilators or short-acting anticholinergics, 72 hours after the
last use of long-acting ß2-agonist bronchodilators and 72 hours after the
last use of long-acting anticholinergics.
8.FEV1/Forced Vital Capacity (FEV1/FVC) = 70% documented at screening
visit
9.Reversibility of FEV1 < 12 % of the initial value 30 minutes after
inhalation of 200µg Salbutamol within the screening period
10.Treatment with any COPD medication at a constant dosage during the last

Exclusion Criteria

All subjects:
1.Blood donation (equal or more than 450 ml) or blood loss less than 8
weeks before the first intake of study drug
2.Positive HIV1 or HIV2 serology
3.Positive results from the Hepatitis serology which indicates acute or
chronic Hepatitis B or Hepatitis C
4.Unsuitable veins for repeated venipuncture
5.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
6.History of substance abuse or drug abuse within 12 months or with a
positive urine drug screen
7.Clinically relevant abnormal laboratory values suggesting an unknown
disease and requiring further clinical investigation
8.Clinically significant and uncontrolled cardiac, hepatic, renal,
gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder
that may interfere with successful completion of this protocol
9.Participation in an investigational drug study within 30 days prior to Visit 1
or current participation in another investigational drug study
10.Known sensitivity to Formoterol or Beclomethasone or any of the
excipients contained in any of the formulations used in the trial.
11.Concomitant severe diseases or diseases which are contra indications for
the use of inhaled ?2-agonist or steroids.
12.Use of any prescription drug for which concomitant beta-agonist or steroid
administration are contraindicated.
13.History of significant sensitivity, allergy or intolerance to study drug
formulation ingredients.
14.Recent relevant infectious disease (less than two months)
15.Flu vaccination within 4 weeks prior to the screening visit
16.Other vaccination within 4 weeks prior to the screening visit

Additional exclusion criteria for patients with Asthma:
1.Use of systemic steroids 4 weeks prior to inclusion (injectable depot
steroids 6 weeks) or more than 3 periods during the last 6 months
2.Life-threatening/unstable respiratory status including upper or lower
respiratory tract infection, within the previous 30 days
3.Requirement of continuous supplemental oxygen therapy; the use of
supplemental oxygen not exceeding 2l/min, at night time only and/or only
during exercise is allowed
4.Change in dose or type of any medications for asthma within 4 weeks
prior to the screening visit
5.Asthma exacerbation within the 4 weeks prior to inclusion

Additional exclusion criteria for patients with COPD:
1.Use of systemic steroids 4 weeks prior to inclusion (injectable depot
steroids 6 weeks) or more than 3 periods during the last 6 months
2.Life-threatening/unstable respiratory status including upper or lower
respiratory tract infection, within the previous 30 days
3.Requirement of continuous supplemental oxygen therapy; the use of
supplemental oxygen not exceeding 2l/min, at night time only and/or only
during exercise is allowed
4.Change in dose or type of any medications for COPD within 4 weeks prior
to the screening visit
5.COPD exacerbation within the 4 weeks prior to inclusion
6.History of asthma or any ch

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 the study is to assess intrapulmonary deposition of Foster.;Secondary Objective: Secondary objective is to describe intrapulmonary distribution, pharmacokinetic properties of the drug formulation and evaluation of the lung function.;Primary end point(s): Intrapulmonary deposition