Bronchial Asthma Clinical Trial
Official title:
Double Blind, Double Dummy, Multinational, Multicentre, Parallel-Group Design Clinical Trial of the Efficacy and Tolerability of CHF 1535 (Beclomethasone Dipropionate 100 µg + Formoterol 6 µg) pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler® (Symbicort®) in the 12-Week Treatment of Adult Patients With Moderate to Severe Persistent Asthma
Verified date | July 2020 |
Source | Chiesi Farmaceutici S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.
Status | Completed |
Enrollment | 219 |
Est. completion date | October 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of moderate to severe persistent asthma for at least 6 months, according to GINA revised version 2002 guidelines: - Forced expiratory volume (FEV1) or peak expiratory flow rate (PEFR) > 50% and < 80% of the predicted normal; - Asthma not adequately controlled with the current therapies, defined as presence of daily asthma symptoms > once a week and night-time asthma symptoms > twice a month, and daily use of short-acting ß2-agonists. These findings are to be based on recent medical history and are to be confirmed in the 2-week run-in period. - Treatment with inhaled corticosteroids at a daily dose = 1000 µg of BDP or equivalent. The daily dose of inhaled corticosteroids taken at visit 1 will be assessed taking into account the following ratios between the doses of the different steroids: fluticasone propionate : BDP CFC = 1 : 2; budesonide : BDP CFC = 4 : 5; flunisolide : BDP CFC = 1 : 1. The ratios between inhaled steroids are irrespective of the formulations (i.e. spray aerosol or powder) used. When BDP is given in the new extra-fine HFA-134a formulation (as QVAR®, 3M Healthcare), the ratio with BDP CFC is set as 2 : 5. Therefore, the maximum allowed daily dose of inhaled corticosteroids at study entry will be: budesonide 800 µg, fluticasone propionate 500 µg, flunisolide 1000 µg, BDP 1000 mcg, BDP HFA extra-fine 400 µg. - Positive response to the reversibility test in the screening visit, defined as an increase of at least 12% (or, alternatively, of 200mL) from baseline value in the measurement of FEV1 30 minutes following 2 puffs (2 x 100 µg) of inhaled salbutamol administered via pMDI. The reversibility test can be avoided in patients having a documented positive response in the previous 6 months. - A co-operative attitude and ability to be trained to correctly use the metered dose inhalers and to complete the diary cards. - Written informed consent obtained. - At the end of the 2-week run-in period, the presence of daily asthma symptoms (of at least mild intensity) and nighttime asthma symptom (of at least mild intensity) > once a week, as well as of daily use of relief salbutamol is to be confirmed by reviewing the diary cards for run-in Exclusion Criteria: - Inability to carry out pulmonary function testing; - Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (30); - History of near fatal asthma; - Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 8 weeks; - Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months; - Patients treated with long-acting ß2-agonists, anticholinergics and antihistamines during the previous 2 weeks, with topical or intranasal corticosteroids and leukotriene antagonists during the previous 4 weeks; - Patients who have changed their dose of inhaled corticosteroids during the previous 4 weeks, or treatment with inhaled corticosteroids at a daily dose > 1000 µg of BDP or equivalent (except for extra-fine formulations, see inclusion criteria); - Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day; - History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; - Diabetes mellitus; - Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months; - Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females; - Other haemodynamic relevant rhythm disturbances (including atrial flutter or atrial fibrillation with ventricular response, bradycardia (= 55 bpm), evidence of atrial-ventricular (AV) block on ECG of more than 1st degree; - Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g. active peptic ulcer), neurological or haematological autoimmune diseases; - Cancer or any chronic diseases with prognosis < 2 years; - Pregnant or lactating females or females at risk of pregnancy, i.e. those not demonstrating adequate contraception (i.e. barrier methods, intrauterine devices, hormonal treatment or sterilization). A pregnancy test is to be carried out in women of a fertile age. - History of alcohol or drug abuse; - Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use; - Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients; - Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; - Patients who received any investigational new drug within the last 12 weeks; - Patients who have been previously enrolled in this study; - At the end of the run-in period, patients will not be admitted to the treatment period in the case of an increase of PEFR (L/sec) measured at the clinics at the end of the run-in period > 15% in respect of values measured at the start of the run-in period; - Patients with asthma exacerbations during the run-in period will also be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Austria | Ambulance For Paediatric and Pulmonology | Wien | |
Poland | Nzoz "Medex"Poradnia Alergologiczna | Bielsko-Biala | |
Poland | Centrum Uslug Medycznych | Krakow | |
Poland | Centrum Alergologii | Lodz | |
Poland | Prywatny Gabinet Lekarski | Lodz | |
Poland | Uniwersytet Medyczny | Lodz | |
Poland | Nzoz Lekarze Specjalisci | Wroclaw | |
Ukraine | Internal Medicine Department, Dniepropetrovsk State Medical Academy. City Clinical Hospital no. 4 | Dniepropetrovsk | |
Ukraine | Institute of Therapy, Ukranian Academy of Medical Science. Pulmonological Departement | Kharkiv | |
Ukraine | Kharkov Regional Clinical Hospital. Pulmonological and Allergological Department | Kharkov | |
Ukraine | Institute of Phthisiology and Pulmonology Academy of Medical Science of the Ukraine, Pulmonology Departement | Kiev | |
Ukraine | Institute of Phthisiology and Pulmonology Academy of Medical Science of the Ukraine. Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Diseases | Kiev | |
Ukraine | Kiev Medical Academy of Postdiploma Education. Department of Medical Genetics, Clinical Immunology and Allergology | Kiev |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. |
Austria, Poland, Ukraine,
Papi A, Paggiaro PL, Nicolini G, Vignola AM, Fabbri LM; Inhaled Combination Asthma Treatment versus SYmbicort (ICAT SY) Study Group. Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma. Eur Respir J. 2007 Apr;29(4):682-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morning Peak Expiratory Flow (PEF) daily measured by patients. | morning approximately 8:00 | ||
Secondary | Evening PEF measured by patients daily. | evening approximately 20:00 | ||
Secondary | FEV1 measured by patients daily. | morning and evening | ||
Secondary | Standard pulmonary function tests measured at clinics at 2, 4, 8 and 12 weeks. | morning before drug intake | ||
Secondary | Change in FEV1 and PEF from pre-dose to 5, 15, 30 and 60 minutes after study drug intake at week 0 and 12. | morning post drug intake | ||
Secondary | Symptoms scores measured by patients daily. | morning and evening | ||
Secondary | symptoms'free days measured by patients daily. | daily | ||
Secondary | Use of relief salbutamol measured by patients daily. | daily | ||
Secondary | Frequency of asthma exacerbations evaluated at 2, 4, 8 and 12 weeks. | morning of the visits retrospective assessment | ||
Secondary | Adverse event and adverse drug reaction daily. | morning of visits retrospective assesment | ||
Secondary | ECG (with QTc interval)at 0 and 12 weeks. | morning of start and end of treatment visits | ||
Secondary | Vital signs (heart rate and blood pressure) at 2, 4, 8 and 12 weeks | morning of visits | ||
Secondary | Use of relief salbutamol. | daily | ||
Secondary | Frequency of asthma exacerbations. | at visits |
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