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Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma (FORTINO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255579
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
Information provided by:
Università degli Studi di Brescia

Brief Summary:

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 or disease Intervention/treatment Phase
Bronchial Asthma Drug: Salmeterol Fluticasone Drug: formoterol - beclometasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : July 2007
Actual Primary Completion Date : December 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Small airways obstruction [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255579

Sponsors and Collaborators
Università degli Studi di Brescia
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Study Chair: Claudio Tantucci, MD Università degli Studi di Brescia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Claudio Tantucci, Università degli Studi di Brescia Identifier: NCT01255579    
Other Study ID Numbers: Tantucci_1
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2008
Keywords provided by Università degli Studi di Brescia:
small airways
inhaled corticosteroids
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action