As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma

Asthma Clinical Trial

Official title:

Multinational, Double Blind, Randomised, Parallel Group Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate 250 mg Combined With Salbutamol 100 mg in the Treatment of Patients With Mild Persistent Asthma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382889
• Other study ID #: MC/PR/1401/001/01
• Status: Completed
• Phase: Phase 3
• Start date: August 2002
• Est. completion date: September 2004

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. better compliance with treatment since patients will most likely have to administer the treatment less frequently,

2. maximum pharmacological effect with the least amount of drug and

3. less economic burden on health care providers.

Description:

Asthma is widely recognised as a chronic inflammatory disorder of the airways. The 1997 American National Heart Lung and Blood Institute (NHLBI) Guidelines states that a firm scientific basis exists to indicate that asthma results from complex interactions among inflammatory cells, mediators and the cells and tissues resident in the airways.

Despite the existence of effective therapy people still die from asthma. It is pertinent to state that the clinical effect of a drug is not only dependent on the specific action of the drug, but also on the patient's way of using it. Therefore, compliance is an important factor especially for chronic disorders such as asthma. Indeed, non compliance with asthma therapy is a serious problem. It has been reported that drug side effects, lifestyle, social and economic factors, method of drug delivery and dosing are factors that contribute to poor compliance. The consequences of poor compliance lead to increased morbidity due to increased symptoms and asthma exacerbation.

The NHLBI Guidelines recommend daily treatment for patients with mild persistent asthma with inhaled glucocorticoids (200-500mcg/die) and short-acting bronchodilators as needed but no more than 3-4 times a day.

Comparisons: beclomethasone dipropionate 250 mg combined with salbutamol 100 mg "as needed", vs salbutamol 100 mg alone "as needed", vs beclomethasone 250 mg twice a day plus salbutamol 100 mg "as needed" and vs beclomethasone dipropionate 250 mg combined with salbutamol 100 mg twice a day plus salbutamol 100 mg "as needed", in the treatment of patients with mild persistent asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• beclomethasone/salbutamol combination

• beclomethasone

• salbutamol

Locations

Country	Name	City	State
Austria	Ambulance for pediatrics and Pneumology	Wien
Austria	Pulmologisches Zentrum Der Stadt Wien	Wien
Italy	Dip. di Pneumologia - Osp. Tommaselli	Catania
Italy	Nuove Cliniche Arcispedale S.Anna	Ferrara
Italy	DIMI - Dip. Medicina Interna - Univ. di Genova - clinica di malattie apparato respiratorio e allergologico	Genova
Italy	Dipartimento di scienze mediche oncologiche e radiologiche - sez. malattie apparato respiratorio	Modena
Italy	Univ. di Padova - Dipartimento di medicina ambientale e sanità pubblica	Padova
Italy	Istituto di Fisiopatologia Respiratoria CNR - Ospedale Cervello	Palermo
Italy	Clinica Pneumologica padiglione Rasori - Univ. di Parma	Parma
Italy	Clinica di Malattie dell'Apparato Respiratorio dell'Univ. di Pavia - Policlinico S. Matteo	Pavia
Italy	Reparto Fisiologia Respiratoria - dip. Cardiotoracico - Ospedale Cisanello	Pisa
Poland	Outpatient Clinic of Internal Diseases and Allergology	Bialystok
Poland	Specialist Group Medex	Bielsko Biala
Poland	Clinic of Internal Diseases Atopia Al.	Krakow
Poland	Pulmonologic Clinic - Poludnie os. Krakowiakòw	Krakow
Poland	Clinic of Pneumology and Allergology	Lòdz
Poland	Clinic of Tubercolosis and Lung Diseases	Lòdz
Poland	Clinic of Pneumology - Institute of Internal Medicine of Medical Academy	Lódz
Poland	Institute of Occupational Medicine - Clinic of Occupational Disesase	Lódz
Poland	Clinic of Infection Diseases and Allergology - Central Clinical Hospital of Military Medical Academy	Warszawa
Poland	Clinic of Pneumology and Allergology A.M.	Warszawa
Poland	Clinic of Pneumology and Allergology of Medical Academy	Warszawa
Spain	H.General de Vic, Servicio de Neumologia	Barcelona
Spain	Hospital Vall d'Hebron de Barcelona	Barcelona
Spain	Hospital de Matarò	Mataro

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Austria,  Italy,  Poland,  Spain, 

References & 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of exacerbations
Secondary	Time to first severe exacerbation
Secondary	Improvement of asthma symptoms (symptom scores)
Secondary	Need for short acting b2 agonists
Secondary	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
Secondary	evening PEF
Secondary	Diurnal variability of PEF
Secondary	Nocturnal asthma (nocturnal awakening because of asthma)
Secondary	Nights and days without asthma symptoms (score 0)