A study, 12 weeks, conducted in more centers, treatment with randomly assigned, double-blind, ''double-dummy'', in two parallel groups to compare the efficacy and safety of the combination of Foster NEXThaler ? ?, 2 inhalations bid, compared to Seretide Accuhaler ? ?, 1 inhalation, the derived parameters of small airways in patients with asthma
- Conditions
- AsthmaMedDRA version: 14.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-003449-17-IT
- Lead Sponsor
- CHIESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Male or female outpatients aged = 18, who have signed an Informed Consent form prior to initiation of any study-related procedure. 2. Clinical diagnosis of asthma for a minimum of 12 months prior to screening confirmed by a chest physician according to international guidelines (GINA). The evidence of asthma must be confirmed through a documented (in the last three years) positive response to the reversibility test, defined as ?FEV1 = 12% and = 200 mL over baseline, within 30 minutes after administration of 400 µg of salbutamol pMDI or through a documented (in the last three years) positive response to methacholine challenge test (PC20 < 8 mg/mL or PD20 < 1 mg). 3. Baseline FEV1 > 80% of the predicted normal value after appropriate washout from bronchodilators (to be checked at screening and at randomisation visits). 4. Asthma Control Test score = 20 and < 25 (to be checked at screening and at randomisation visits). 5. Impaired small airways function defined as baseline peripheral airway resistance [R(5Hz)-R(20Hz)] = 0.07 kPa/L/s (to be checked at screening and at randomisation visits). 6. Patients on previous regular treatment with Seretide Accuhaler(fluticasone propionate 250 µg plus salmeterol xinafoate 50 µg per actuation, daily dose of fluticasone 500 µg plus salmeterol 100 µg) at a stable dose for at least 2 months prior to inclusion. 7. A cooperative attitude and ability to be trained to the proper use of DPI.
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) no
F.1.3.1 Number of subjects for this age range
1.Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or are using one or more acceptable methods of contraception 2.Inability to comply with study procedures or with study treatment intake. 3. Intermittent asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer. 4. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease. 5. Patients with a diagnosis of COPD according to GOLD guidelines. 6. Current smokers with a smoking history of > 10 pack/year. 7. Diagnosis of restrictive lung disease. 8. Patients who have a clinical or functional 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. 9. History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias. 10. Patients who have a concomitant disease of poor prognosis (e.g. cancer). 11. Clinically relevant laboratory abnormalities such as (but not limited to) hypokalemia (< 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 serum glucose levels consistently out of the normal range (> 140 mg/dL) or HbA1C > 8.0%. 12. 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). 13. Intolerance or contra-indication to treatment with ß2-agonists and/or ICS or allergy to any component of the study treatments. 14. Patients treated with slow-release corticosteroids in the 3 months prior to screening visit. 15. 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. 16. Patients treated with LABA or ICS/LABA fixed combination in the 24 hours before the screening visit. 17. Patient having received an investigational drug within 2 months before the screening visit. 18. Severe asthma exacerbation leading to intake of systemic corticosteroids (> 10 days) in the month before the screening visit. 19. Patient with lower respiratory tract infections (e.g. pneumonia) affecting the patient’s asthma in the month before the screening visit. 20. Patients treated with non-potassium sparing diuretics (unless administered at a fixed dose combination with a potassium conserving drug), non-selective ß1-blocking drugs, quinidine, quinidine-like antiarrhythmics, or any medication with a QTc prolongation potential or a history of QTc prolongation. 21. Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, unless already taken at stable doses in the month before the screening visit. 22. Patients who are receiving therapy that could interact with steroids, such as enzyme inhibitors [macrolides, antifungal therapy (not topical)] or induced (anticonvulsants, rifampicin). 23. Patients under treat
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 better efficacy of Foster NEXThaler 100/6 extrafine (two inhalations b.i.d.) versus Seretide Accuhaler 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.;Secondary Objective: To evaluate the effect of the treatments on additional lung function parameters and clinical outcome measures, and to assess the safety of study treatments.;Primary end point(s): Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)].;Timepoint(s) of evaluation of this end point: 17 months
- Secondary Outcome Measures
Name Time Method