Multicentre, randomized research study to test the safety and efficacy of Foster® compared to Symbicort® on small airway function in patients with COPD (Chronic Obstructive Pulmonary Disease)

• Conditions: Male or female patients aged more or equal than 40 years with Chronic Obstructive Pulmonary Disease; MedDRA version: 14.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-022895-30-NL
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-23
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1.Male or female patients aged = 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative.
2.Outpatients with a clinical diagnosis of moderate to severe COPD and including:
a)Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking)] / 20, both current and ex-smokers are eligible.
b)Regular use of bronchodilators (e.g. ß2-agonist, anticholinergics) in the 2 months before visit 1.
c)Post-bronchodilator FEV1 < 65% of the predicted normal value at visit 1.
d)Post-bronchodilator FEV1/FVC < 0.7 at visit 1.
e)An increase in FEV1 < 15% and < 200 mL from baseline following administration of 400 µg of salbutamol at visit 1.
f)Plethysmographic Functional Residual Capacity (FRC) > 120% of the predicted normal value (at visit 1 and visit 2).
g)A Baseline Dyspnoea Index (BDI) focal score < or = 10 (at visit 1 and at visit 2).
3.A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Turbohaler®, inspiratory flow-driven, multidose powder inhaler) inhalers.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator’s opinion.
2.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) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
d) Continuous abstinence (e.g. nuns).
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.
3.Clinically unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator’s judgement.
4.Patient with narrow-angle glaucoma.
5.Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which may impact the evaluation of the results of the study and the safety of the patient according to investigator’s judgement.
6.Patients with COPD exacerbation and/or symptomatic infection of the airways requiring antibiotic therapy (at least 5 days) in the 2 months prior to screening and during the study period. 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 (at least 3 days) and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization”.
7.Patients requiring long term (> 12 hours daily) oxygen therapy for chronic hypoxemia.
8.Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
9.Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs.
10.Patients who have evidence of alcohol or drug abuse, not compliant with the study protocol or not compliant with the study treatments according to investigator’s judgement.
11.Major surgery in the previous 3 months and during the trial which may affect patient’s compliance in study procedures (e.g. plethysmography).
12.Participation in another clinical trial with an investigational drug in the 2 months preceding visit 1.
13.Patients requiring chronic mechanical ventilation for COPD.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction in patients with Chronic Obstructive Pulmonary Disease.;Secondary Objective: To evaluate the efficacy of the test treatments in terms of reduction of symptoms, improvements in health status (assessed by specific questionnaires) and in parameters related to small airway function in patients with Chronic Obstructive Pulmonary Disease, and to assess the safety of study treatments.;Primary end point(s): Change from baseline to end of treatment in post-dose residual volume;Timepoint(s) of evaluation of this end point: Primary Endpoint will be evaluated at w0 (pre-dose, 120 min and 180 min post-dose), w4 (pre-dose, 120 min and 180 min post-dose) and w12 (pre-dose, 120 min and 180 min post-dose)