Status:
COMPLETED
Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma
Lead Sponsor:
Università degli Studi di Ferrara
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Study No.001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether asthma not controlle...
Detailed Description
Asthma is a problem worldwide, with an estimated 300 million affected individuals.There is evidence that asthma prevalence has been increasing in the last decades in some countries, including Italy. A...
Eligibility Criteria
Inclusion
- Male or female out-patient aged from 18 years to 65 years
- Clinical diagnosis of moderate persistent asthma for at least 6 months, according to GINA revised version 2006 guidelines
- Post-bronchodilator forced expiratory volume (FEV1) at least 80% of the predicted
- Either positive methacholine challenge test (PC20 FEV1\< 4mg/ml or PD20 FEV1\<0.8 mg) or positive response to the reversibility test in the last year
- Asthma either not adequately controlled with low-dose (≤500 mcg beclomethasone or equivalent) inhaled corticosteroids (ICS) or controlled by bid inhaled combination of low-dose ICS/long acting beta-2 agonists (LABA)
- A co-operative attitude and ability to be trained to correctly use the dry powder inhalator and to complete the diary cards
- Written informed consent obtained
Exclusion
- Inability to carry out pulmonary function testing
- Moderate severe asthma associated with reduced lung function
- History of near-fatal asthma and/or admission intensive care unit because of asthma
- 3 or more courses of oral corticosteroids or hospitalization for asthma during the previous year
- Diagnosis of COPD as defined by the GOLD guidelines
- Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 8 weeks
- Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 pack/years
- History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, or cardiac arrhythmias
- Diabetes mellitis
- Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months
- Abnormal ECG
- Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g., active peptic ulcer), neurological or haematological autoimmune diseases
- Malignancy
- Any chronic diseases with prognosis \< 2 years
- Pregnant or lactating females or not able to exclude pregnancy during the study period
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
860 Patients enrolled
Trial Details
Trial ID
NCT00849095
Start Date
April 1 2009
End Date
May 1 2013
Last Update
May 30 2014
Active Locations (31)
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1
Ospedale regionale Umberto I, Unità Operativa di Allergologia
Ancona, AN, Italy
2
Fondazione S. Maugeri - IRCCS -dipartimento di Pneumologia riabilitativa
Cassano delle Murge, BA, Italy
3
Dipartimento di Scienze Mediche-Unità Operativa di Pneumologia
Benevento, BN, Italy, 82100
4
Policlinico Sant'Orsola Malpighi, Unità Operativa di Pneumologia
Bologna, BO, Italy