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

Sponsor

Chiesi Farmaceutici S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT00382889

Collaborator

(none)

480

Enrollment

Locations

Duration (Months)

19.2

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: beclomethasone/salbutamol combination Drug: beclomethasone Drug: salbutamol	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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.

Study Start Date :

Aug 1, 2002

Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 []
evening PEF []
Diurnal variability of PEF []
Nocturnal asthma (nocturnal awakening because of asthma) []
Nights and days without asthma symptoms (score 0) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ambulance for pediatrics and Pneumology	Wien	Austria
2	Pulmologisches Zentrum Der Stadt Wien	Wien	Austria
3	Dip. di Pneumologia - Osp. Tommaselli	Catania	Italy
4	Nuove Cliniche Arcispedale S.Anna	Ferrara	Italy
5	DIMI - Dip. Medicina Interna - Univ. di Genova - clinica di malattie apparato respiratorio e allergologico	Genova	Italy
6	Dipartimento di scienze mediche oncologiche e radiologiche - sez. malattie apparato respiratorio	Modena	Italy
7	Univ. di Padova - Dipartimento di medicina ambientale e sanità pubblica	Padova	Italy
8	Istituto di Fisiopatologia Respiratoria CNR - Ospedale Cervello	Palermo	Italy
9	Clinica Pneumologica padiglione Rasori - Univ. di Parma	Parma	Italy
10	Clinica di Malattie dell'Apparato Respiratorio dell'Univ. di Pavia - Policlinico S. Matteo	Pavia	Italy
11	Reparto Fisiologia Respiratoria - dip. Cardiotoracico - Ospedale Cisanello	Pisa	Italy
12	Outpatient Clinic of Internal Diseases and Allergology	Bialystok	Poland
13	Specialist Group Medex	Bielsko Biala	Poland
14	Clinic of Internal Diseases Atopia Al.	Krakow	Poland
15	Pulmonologic Clinic - Poludnie os. Krakowiakòw	Krakow	Poland
16	Clinic of Pneumology and Allergology	Lòdz	Poland
17	Clinic of Tubercolosis and Lung Diseases	Lòdz	Poland
18	Clinic of Pneumology - Institute of Internal Medicine of Medical Academy	Lódz	Poland
19	Institute of Occupational Medicine - Clinic of Occupational Disesase	Lódz	Poland
20	Clinic of Infection Diseases and Allergology - Central Clinical Hospital of Military Medical Academy	Warszawa	Poland
21	Clinic of Pneumology and Allergology A.M.	Warszawa	Poland
22	Clinic of Pneumology and Allergology of Medical Academy	Warszawa	Poland
23	Hospital Vall d'Hebron de Barcelona	Barcelona	Spain	08035
24	H.General de Vic, Servicio de Neumologia	Barcelona	Spain	08500
25	Hospital de Matarò	Mataro	Spain	08304

Sponsors and Collaborators

Chiesi Farmaceutici S.p.A.

Investigators

Principal Investigator: Leonardo M Fabbri, MD, Clinica di Malattie dell'Apparato Respiratorio, Dipartimento di Oncologia, Ematologia e Pneumologia, Università di Modena e Reggio Emilia, Italy