A 48-week, multicentre, multinational, randomized, double-blind, 2-arm parallel group study, comparing the efficacy of FOSTER™ for maintenance and reliever versus fixed-dose FOSTER™ for maintenance + salbutamol as reliever in asthmatics =18 years of age

• Conditions: asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2008-004671-22-GB
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-28
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2404

Inclusion Criteria

1. Written signed and dated informed consent obtained.
2. Male or female patients aged = 18 years.
3. Clinical diagnosis of asthma for = 6 months.
4. A positive reversibility test, defined as an increase of at least 12% and at least 200 mL from pre-dose in FEV1 30 minutes following 4 puffs (4 × 100 µg) of inhaled salbutamol pMDI. In case this can not be achieved, a documented reversibility test to salbutamol within the last 6 months is acceptable for eligibility.
5. Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month), defined as deterioration in asthma resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for = 3 days because of asthma.
6. Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose (changes in doses for less than seven days are accepted) for two months before V1.
In case patients are under ICS only, the daily dose must be = non-extrafine 1000 µg BDP or equivalent.
In case patients are under ICS + LABA, the ICS daily dose must be = non-extrafine 500 µg BDP or equivalent. LABA should be stopped at least 24h before V1.
7. Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007)(apart of asthma exsacerbation criteria) in the last month before V1.
8. Forced expiratory volume in the first second (FEV1) = 60% of predicted for the patient normal value.
9. Non smokers or ex-smokers (defined as those who stopped smoking for more than one year and with a smoking history less than 10 pack/year).
10. A co-operative attitude and ability to be trained to correctly use the pMDI.
11. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5 mIU/mL). Woman of child-bearing potential unless using an acceptable method of contraception
2. Body Mass Index (BMI) > 34 kg/m2.
3. Patient with lower respiratory tract infections affecting the patient’s asthma within 30 days of the screening visit.
4. Use of systemic steroids in the last month.
5. Patients with other lung diseases such as (but not limited to) COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder.
6. Patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study.
7. History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias.
8. Cancer or any other chronic disease with poor prognosis (less of 2 years) and /or affecting patient status.
9. Clinically relevant laboratory abnormalities such as (but not limited to) hypokaliemia (<3.5 mEq/L), that might compromise patient’s safety or compliance, interfere with evaluation, or preclude completion of the study, in the judgment of the investigator. Patients with uncontrolled diabetes including patients with a history of plasma glucose levels consistently out of the normal range (> 140 mg /dl) or HbA1C > 8.0%.
10. Patients who have an abnormal QTcF interval value in the screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females).
11. Intolerance or contra-indication to treatment with b2-agonists and/or ICS or allergy to any component of the study treatments.
12. Patients treated with slow-release corticosteroids in the 3 months prior to screening visit
13. Patients unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments.
14. Patients being treated with anti-IgE antibodies.
15. Patients treated with LABA or ICS/LABA fixed combination in the 24h before Visit 1.
16. Patient having received an investigational drug within 2 months before the screening visit.
17. Inability to comply to study procedures or to study treatment intake.
18. Inability to carry out a valid spirometry.
19. Severe asthma exacerbation in the last month before screening visit.
20. Severe asthma exacerbation during the run-in period.

Study & Design

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