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

July 30, 2020 updated by: Chiesi Farmaceutici S.p.A.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • Ambulance for pediatrics and Pneumology
      • Wien, Austria
        • Pulmologisches Zentrum Der Stadt Wien
  • Italy
      • Catania, Italy
        • Dip. di Pneumologia - Osp. Tommaselli
      • Ferrara, Italy
        • Nuove Cliniche Arcispedale S.Anna
      • Genova, Italy
        • DIMI - Dip. Medicina Interna - Univ. di Genova - clinica di malattie apparato respiratorio e allergologico
      • Modena, Italy
        • Dipartimento di scienze mediche oncologiche e radiologiche - sez. malattie apparato respiratorio
      • Padova, Italy
        • Univ. di Padova - Dipartimento di medicina ambientale e sanità pubblica
      • Palermo, Italy
        • Istituto di Fisiopatologia Respiratoria CNR - Ospedale Cervello
      • Parma, Italy
        • Clinica Pneumologica padiglione Rasori - Univ. di Parma
      • Pavia, Italy
        • Clinica di Malattie dell'Apparato Respiratorio dell'Univ. di Pavia - Policlinico S. Matteo
      • Pisa, Italy
        • Reparto Fisiologia Respiratoria - dip. Cardiotoracico - Ospedale Cisanello
  • Poland
      • Bialystok, Poland
        • Outpatient Clinic of Internal Diseases and Allergology
      • Bielsko Biala, Poland
        • Specialist Group Medex
      • Krakow, Poland
        • Clinic of Internal Diseases Atopia Al.
      • Krakow, Poland
        • Pulmonologic Clinic - Poludnie os. Krakowiakòw
      • Lòdz, Poland
        • Clinic of Pneumology and Allergology
      • Lòdz, Poland
        • Clinic of Tubercolosis and Lung Diseases
      • Lódz, Poland
        • Clinic of Pneumology - Institute of Internal Medicine of Medical Academy
      • Lódz, Poland
        • Institute of Occupational Medicine - Clinic of Occupational Disesase
      • Warszawa, 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
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron de Barcelona
      • Barcelona, Spain, 08500
        • H.General de Vic, Servicio de Neumologia
      • Mataro, Spain, 08304
        • Hospital de Mataro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

September 29, 2006

First Submitted That Met QC Criteria

September 29, 2006

First Posted (ESTIMATE)

October 2, 2006

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC/PR/1401/001/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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