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

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ClinicalTrials.gov Identifier: NCT00382889
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : August 3, 2020
Information provided by:
Chiesi Farmaceutici S.p.A.

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. 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.

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 480 participants
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 : August 2002
Study Completion Date : September 2004

Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of exacerbations
  2. Time to first severe exacerbation
  3. Improvement of asthma symptoms (symptom scores)
  4. Need for short acting b2 agonists
  5. 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
  6. evening PEF
  7. Diurnal variability of PEF
  8. Nocturnal asthma (nocturnal awakening because of asthma)
  9. Nights and days without asthma symptoms (score 0)

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382889

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Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
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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 of Results:
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ClinicalTrials.gov Identifier: NCT00382889    
Other Study ID Numbers: MC/PR/1401/001/01
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Keywords provided by Chiesi Farmaceutici S.p.A.:
Anti-Asthmatic Agents
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists