Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma (FORTINO)
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Purpose
New formulations of extrafine particles of long acting beta-2 agonists+inhaled corticosteroids (LABA+ICS) are able to reach more peripheral regions of the lung.
Objectives.The aim of this study was to assess the effect on small airways obstruction of long-term treatments with two different LABA+ICS combinations in asthma.
Patients and methods.Ten subjects with moderate persistent asthma were enrolled. After a 4-week washout they were treated in a randomized cross-over design for 24 weeks with formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d. (FB) or salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d. (SF). At baseline and at the end of each period subjects underwent Asthma Control Test (ACT) and Pulmonary Function Testing. The N2 phase III slope and closing volume (CV) during single breath washout test, and DElta(Heliox-air)MEF50% were measured to assess changes on peripheral airways function.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchial Asthma |
Drug: Salmeterol Fluticasone Drug: formoterol - beclometasone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects on Small Airways Obstruction of Two Long-term Treatments With Extrafine Beclomethasone/Formoterol vs Fluticasone/Salmeterol in Asthma |
- Small airways obstruction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | July 2007 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: SF
Extrafine Fluticasone/Salmeterol
|
Drug: Salmeterol Fluticasone
salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d.
Other Name: SERETIDE
|
|
Active Comparator: FB
Extrafine Formoterol and beclometasone HFA
|
Drug: formoterol - beclometasone
formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d.
Other Name: FOSTER
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Moderate persistent bronchial asthma according to GINA guidelines
Exclusion Criteria:
Associated respiratory diseases Smoking history Oral corticosteroid in the previous six months Pregnant women
Contacts and Locations More Information
No publications provided by Università degli Studi di Brescia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Claudio Tantucci, Università degli Studi di Brescia |
| ClinicalTrials.gov Identifier: | NCT01255579 History of Changes |
| Other Study ID Numbers: | Tantucci_1 |
| Study First Received: | December 6, 2010 |
| Last Updated: | December 6, 2010 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Università degli Studi di Brescia:
|
asthma small airways inhaled corticosteroids |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Beclomethasone Fluticasone, salmeterol drug combination Formoterol Salmeterol Albuterol |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013