Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma - Full Text View

Sponsor:	Universitaria di Ferrara
Information provided by:	Universitaria di Ferrara
ClinicalTrials.gov Identifier:	NCT00849095

Purpose

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 controlled by low doses inhaled corticosteroids, thus in need for step up therapy, can be equally controlled by guidelines recommended regular bid treatment with long acting beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol (experimental treatment) versus regular, twice daily 160/4.5 mcg inhaled budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended treatment).

Condition	Intervention	Phase
Asthma	Drug: budesonide/formoterol combination (PRN) Drug: budesonide/formoterol combination Drug: placebo Drug: terbutaline	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	As Needed Budesonide/Formoterol Combination Versus Regular Budesonide/Formoterol Combination Plus Pas Needed Terbutaline in Mild-Moderate Persistent Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Terbutaline Terbutaline sulfate Formoterol fumarate Budesonide Arformoterol Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Universitaria di Ferrara:

Primary Outcome Measures:

comparison between groups of the relative risk for treatment failure [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

number of treatment failures and of drop-out [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
time to first treatment failure and to drop-out [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
differences between groups of lung function parameters, quality of life, symptoms score, use of as needed medication, adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	960
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
as needed medication: Experimental patients assigned to this arm will take bid inhaled placebo plus prn inhaled 160/4.5 mcg budesonide/formoterol combination	Drug: budesonide/formoterol combination (PRN) budesonide/formoterol combination 160/4.5 mcg 1 inhalation used as needed for a period of 52 weeks Drug: placebo bid inhaled placebo
guideline treatment: Active Comparator bid inhaled 160/4.5 mcg budesonide/formoterol combination plus prn 500 mcg terbutaline	Drug: budesonide/formoterol combination budesonide/formoterol 160/4.5 mcg 1 inhalation bid Drug: terbutaline as needed terbutaline 500 mcg for a period of 52 weeks

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. Analyses of the cost of asthma lead to conclude that the burden of the disease depend on the extent to which exacerbations are avoided since emergency treatment is more expensive than regular treatment.

Based on solid evidence, international guidelines recommend regular treatment with low dose ICS for mild persistent asthma and treatment with combination therapy [low dose ICS plus long-acting beta2-agonists (LABA)] for patients with asthma not controlled by low doses ICS alone. Recent studies have undermined the axiom that treatment with ICS must be regular to achieve and maintain asthma control, as equivalent control has been obtained either with prn use of an inhaled combination of a short acting beta2 agonist (SABA) and an ICS, or with a short course of 10 days high dose ICS at the start of exacerbations. In moderate-severe asthma regularly treated with inhaled ICS/LABA combination, the symptom-driven use of the same inhaled ICS/LABA combination as reliever is superior to the symptom-driven use of SABA or LABA alone.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849095

Contacts

Contact: Alberto Papi, MD	+390532210420	ppa@unife.it
Contact: Brunilda Marku, MD	+390532236908	brunilda74@hotmail.com

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Sponsors and Collaborators

Universitaria di Ferrara

Investigators

Principal Investigator:

Alberto Papi, MD

Universitaria di Ferrara

More Information

No publications provided

Responsible Party:	Universitaria di Ferrara ( Alberto Papi )
Study ID Numbers:	AIFA-ASMA-BF-001, EudraCT number: 2008-004127-36
Study First Received:	February 20, 2009
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00849095 History of Changes
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Universitaria di Ferrara:

Adult
Asthma
Bronchodilator Agents
Budesonide
Double-Blind Method
Drug Therapy, Combination

Ethanolamines
Female
Forced Expiratory Volume
Humans
Male
Terbutaline

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Terbutaline
Hypersensitivity
Lung Diseases, Obstructive

Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Sympathomimetics
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on February 08, 2010