A 48-week, double-blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of fixed combination” beclomethasone dipropionate plus formoterol fumarate administered via pMDI (CHF 1535 Foster®) versus formoterol in patients with severe chronic obstructive pulmonary disease
- Conditions
- Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
- Registration Number
- EUCTR2009-012546-23-GB
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1102
1. Male and female adults aged > 40 years, who have signed an
Informed Consent form prior to initiation of any study-related
procedure or written informed consent obtained by legal
representative (when applicable).
2. Outpatients with severe COPD (stage III from GOLD guidelines
2008), characterized by shortness of breath, reduced exercise
capacity, fatigue, and repeated exacerbations that almost always
have an impact on patients’ quality of life and including:
a) Smoking history of at least 10 pack years, both current and
ex-smokers are eligible. Ex-smokers will be defined as
subjects who quit smoking at least six months prior to
screening.
b) Post-bronchodilator 30% = FEV1 < 50% of the predicted
normal value.
c) Post-bronchodilator FEV1/FVC < 0.7.
3. A documented (e.g. patient’s records at the admitting hospital)
history of at least one exacerbation in the previous 12 months.
COPD exacerbation will be defined according to the following:
A sustained worsening of the patient’s condition (dyspnoea,
cough and/or sputum production/purulence), from the stable state
and beyond normal day-to-day variations, that is acute in onset
and necessitates a change in regular medication in a patient with
underlying COPD that includes prescriptions of systemic
corticosteroids and/or antibiotics, or need for a visit to an
emergency department or hospitalization”
4. A cooperative attitude and ability to be trained to use correctly
the pMDI inhalers.
5. A cooperative attitude and ability to be trained to recognize
worsening symptoms of COPD and record variations correctly in
the digital platform (BlackBerry®) pre-loaded with the EXACTPRO
questionnaire.
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
1. Pregnant or lactating women. Females of childbearing potential
without an efficient contraception UNLESS they meet the
following definition of post-menopausal: 12 months of natural
(spontaneous) amenorrhea or 6 months of spontaneous
amenorrhea with serum FSH levels > 40 mIU/mL or are using
one or more of the following acceptable methods of
contraception:
a) surgical sterilization (e.g., bilateral tubal ligation,
hysterectomy);
b) hormonal contraception (implantable, patch, oral,
injectable);
c) double-barrier methods (any double combination of: IUD,
male or female condom, diaphragm, sponge, cervical cap).Acceptable methods of contraception may include total
abstinence at the discretion of the investigator in cases where the
age, career, lifestyle, or sexual orientation of the patient ensures
compliance. Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception. Reliable contraception
should be maintained throughout the study and for 30 days after
study drug discontinuation.
2. Diagnosis of asthma.
3. History of allergic rhinitis or other atopic disease (e.g.
eczema).
4. Onset of obstructive symptoms early in life (for example
childhood).
5. Unstable concurrent disease: e.g. uncontrolled
hyperthyroidism, uncontrolled diabetes mellitus or other
endocrine disease; significant hepatic impairment; significant
renal impairment; significant non COPD pulmonary disease (e.g.
tuberculosis, lung cancer or other); cardiovascular disease (e.g.
uncontrolled coronary artery disease, uncontrolled hypertension);
uncontrolled gastrointestinal disease (e.g. active peptic ulcer);
neurological disease; uncontrolled haematological disease;
uncontrolled autoimmune disorders, or other which may impact
the feasibility of the results of the study according to
investigator’s judgement.
6. Evidence of heart failure (NYHA class IV).
7. Clinically significant laboratory abnormalities indicating a
significant or unstable concomitant disease which may impact
the feasibility of the results of the study according to
investigator’s judgement.
8. Patients with serum potassium levels < 3.5 mEq/L (or 3.5
mmol/L).
9. Patient with narrow-angle glaucoma.
10. Patients with COPD exacerbations requiring systemic steroids in
the 4 weeks prior to screening and during the 2 week run-in.
11. Patients requiring long term (at least 12 hours daily) oxygen
therapy for chronic hypoxemia.
12. Patients treated with depot corticosteroids in the two months
preceding the screening visit (Visit 1) and during the run-in
period of the study.
13. Changes in dose, schedule, formulation or pro
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method