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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255579
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
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.
Information provided by:
Università degli Studi di Brescia
  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
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

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Brescia:

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01255579


Sponsors and Collaborators
Università degli Studi di Brescia
Investigators
Study Chair: Claudio Tantucci, MD Università degli Studi di Brescia
  More Information

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
First Submitted: December 6, 2010
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
Last Verified: December 2008

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
Formoterol Fumarate
Salmeterol Xinafoate
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
Glucocorticoids
Hormones