Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01255579
First received: December 6, 2010
Last updated: NA
Last verified: December 2008
History: No changes posted
  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

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 ] [ 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255579

Sponsors and Collaborators
Università degli Studi di Brescia
Investigators
Study Chair: Claudio Tantucci, MD Università degli Studi di Brescia
  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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Beclomethasone
Fluticasone
Fluticasone, salmeterol drug combination
Formoterol
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 24, 2014