NCT00382889

Brief Summary

The aim of this study is to reveal that inhaled corticosteroid therapy combined with a short-acting beta2- agonist given on a symptom driven basis is as effective as traditional asthma therapy. Thus, three advantages will be achieved:

  1. 1.better compliance with treatment since patients will most likely have to administer the treatment less frequently,
  2. 2.maximum pharmacological effect with the least amount of drug and
  3. 3.less economic burden on health care providers.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Aug 2002

Typical duration for phase_3 asthma

Geographic Reach
4 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

First QC Date

September 29, 2006

Last Update Submit

July 30, 2020

Conditions

Asthma

Keywords

Anti-Asthmatic Agentscorticosteroidssymptom-drivenbeclomethasonesalbutamol

Outcome Measures

Primary Outcomes (1)

  • The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)

Secondary Outcomes (9)

  • Number of exacerbations

  • Time to first severe exacerbation

  • Improvement of asthma symptoms (symptom scores)

  • Need for short acting b2 agonists

  • Variation of respiratory parameters (FEV1, PEF, FVC, FEV1/FVC, FEF25-75) immediately before and 30 min after a test with a short-acting b2 agonist

  • +4 more secondary outcomes

Interventions

beclomethasone/salbutamol combinationDRUG
beclomethasoneDRUG
salbutamolDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of mild persistent asthma as defined by NHLBI/WHO 97; for at least 6 months;
  • FEV1 ³ 75% of predicted normal value;
  • Positive response to the reversibility test to b2 agonist, defined as an increase \> 12% in the FEV1 measured 30 minutes following 2 puffs (2x100mg) of inhaled Salbutamol spray, or positive methacholine challenge (PC20\<8mg/ml or PD20\<1 mg) within the previous 6 months;
  • Stable asthma. Asthma is defined stable if none of the following occurred during the last 14 days of the run-in period: diurnal variation of more than 20% in PEF on 2 consecutive days; use of four or more inhalations of b2 agonist per day on two consecutive days; need the use of oral corticosteroids;

You may not qualify if:

  • COPD as defined by the ERS - Consensus Statement;
  • Patients with more than 10 packs/year of cigarettes history and current smokers;
  • History of near fatal asthma and/or admission in intensive care unit because of asthma;
  • One severe exacerbation during the run-in period;
  • Three or more courses of oral corticosteroids or hospitalisation for asthma during the previous 1 year;
  • Patients treated with more than 500 mcg/day of beclomethasone or equivalent for more than 6 months in the previous last year;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Ambulance for pediatrics and Pneumology

Vienna, Austria

Location

Pulmologisches Zentrum Der Stadt Wien

Vienna, Austria

Location

Dip. di Pneumologia - Osp. Tommaselli

Catania, Italy

Location

Nuove Cliniche Arcispedale S.Anna

Ferrara, Italy

Location

DIMI - Dip. Medicina Interna - Univ. di Genova - clinica di malattie apparato respiratorio e allergologico

Genova, Italy

Location

Dipartimento di scienze mediche oncologiche e radiologiche - sez. malattie apparato respiratorio

Modena, Italy

Location

Univ. di Padova - Dipartimento di medicina ambientale e sanità pubblica

Padua, Italy

Location

Istituto di Fisiopatologia Respiratoria CNR - Ospedale Cervello

Palermo, Italy

Location

Clinica Pneumologica padiglione Rasori - Univ. di Parma

Parma, Italy

Location

Clinica di Malattie dell'Apparato Respiratorio dell'Univ. di Pavia - Policlinico S. Matteo

Pavia, Italy

Location

Reparto Fisiologia Respiratoria - dip. Cardiotoracico - Ospedale Cisanello

Pisa, Italy

Location

Outpatient Clinic of Internal Diseases and Allergology

Bialystok, Poland

Location

Specialist Group Medex

Bielsko-Biala, Poland

Location

Clinic of Internal Diseases Atopia Al.

Krakow, Poland

Location

Pulmonologic Clinic - Poludnie os. Krakowiakòw

Krakow, Poland

Location

Clinic of Pneumology and Allergology

Lòdz, Poland

Location

Clinic of Tubercolosis and Lung Diseases

Lòdz, Poland

Location

Clinic of Pneumology - Institute of Internal Medicine of Medical Academy

Lódz, Poland

Location

Institute of Occupational Medicine - Clinic of Occupational Disesase

Lódz, Poland

Location

Clinic of Infection Diseases and Allergology - Central Clinical Hospital of Military Medical Academy

Warsaw, Poland

Location

Clinic of Pneumology and Allergology A.M.

Warsaw, Poland

Location

Clinic of Pneumology and Allergology of Medical Academy

Warsaw, Poland

Location

Hospital Vall d'Hebron de Barcelona

Barcelona, 08035, Spain

Location

H.General de Vic, Servicio de Neumologia

Barcelona, 08500, Spain

Location

Hospital de Matarò

Mataró, 08304, Spain

Location

Related Publications (1)

  • Papi A, Canonica GW, Maestrelli P, Paggiaro P, Olivieri D, Pozzi E, Crimi N, Vignola AM, Morelli P, Nicolini G, Fabbri LM; BEST Study Group. Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma. N Engl J Med. 2007 May 17;356(20):2040-52. doi: 10.1056/NEJMoa063861.

    PMID: 17507703RESULT

MeSH Terms

Conditions

Asthma

Interventions

BeclomethasoneAlbuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, ChlorinatedEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Leonardo M Fabbri, MD

    Clinica di Malattie dell'Apparato Respiratorio, Dipartimento di Oncologia, Ematologia e Pneumologia, Università di Modena e Reggio Emilia, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 2, 2006

Study Start

August 1, 2002

Study Completion

September 1, 2004

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

IT(9)PL(11)ES(3)AU(2)