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

NCT01255579 | Completed Phase 4

• 1 other identifier: Tantucci_1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bronchial Asthma

Keywords

asthma; small airways; inhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

• Small airways obstruction

  24 weeks

Study Arms (2)

SF

ACTIVE COMPARATOR

Extrafine Fluticasone/Salmeterol

Drug: Salmeterol Fluticasone

FB

ACTIVE COMPARATOR

Extrafine Formoterol and beclometasone HFA

Drug: formoterol - beclometasone

Interventions

Salmeterol Fluticasone DRUG

salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d.

Also known as: SERETIDE

SF

formoterol - beclometasone DRUG

formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d.

Also known as: FOSTER

FB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate persistent bronchial asthma according to GINA guidelines

You may not qualify if:

• Associated respiratory diseases Smoking history Oral corticosteroid in the previous six months Pregnant women

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Related Publications (1)

• Corda L, Gardenghi GG, Modina D, Montemurro LT, Novali M, Tantucci C. Effects on small airway obstruction of long-term treatments with beclomethasone/formoterol hydrofluoroalkane (metered-dose inhaler) versus fluticasone/salmeterol (dry-powder inhaler) in asthma: a preliminary study. Allergy Asthma Proc. 2011 Nov-Dec;32(6):29-34. doi: 10.2500/aap.2011.32.3477.

  PMID: 22221427 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination; Foster Home Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Claudio Tantucci, MD

  Università degli Studi di Brescia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Last Updated: December 7, 2010

Record last verified: 2008-12