AsthmaPhase 3NCT00382889
As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma
A Phase 3 study testing beclomethasone/salbutamol combination, beclomethasone and salbutamol in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 25 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- beclomethasone/salbutamol combination, beclomethasone and salbutamol
- How many people
- 480 participants
- Where
- 25 sitesin 4 countries
- Study dates
- Aug 2002to Sep 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
Poland11 sites
Outpatient Clinic of Internal Diseases and Allergology
Bialystok
Specialist Group Medex
Bielsko-Biala
Clinic of Internal Diseases Atopia Al.
Krakow
Pulmonologic Clinic - Poludnie os. Krakowiakòw
Krakow
Clinic of Pneumology - Institute of Internal Medicine of Medical Academy
Lódz
Institute of Occupational Medicine - Clinic of Occupational Disesase
Lódz
Clinic of Pneumology and Allergology
Lòdz
Clinic of Tubercolosis and Lung Diseases
Lòdz
Clinic of Infection Diseases and Allergology - Central Clinical Hospital of Military Medical Academy
Warsaw
Clinic of Pneumology and Allergology A.M.
Warsaw
Clinic of Pneumology and Allergology of Medical Academy
Warsaw
Italy9 sites
Dip. di Pneumologia - Osp. Tommaselli
Catania
Nuove Cliniche Arcispedale S.Anna
Ferrara
DIMI - Dip. Medicina Interna - Univ. di Genova - clinica di malattie apparato respiratorio e allergologico
Genova
Dipartimento di scienze mediche oncologiche e radiologiche - sez. malattie apparato respiratorio
Modena
Univ. di Padova - Dipartimento di medicina ambientale e sanità pubblica
Padova
Istituto di Fisiopatologia Respiratoria CNR - Ospedale Cervello
Palermo
Clinica Pneumologica padiglione Rasori - Univ. di Parma
Parma
Clinica di Malattie dell'Apparato Respiratorio dell'Univ. di Pavia - Policlinico S. Matteo
Pavia
Reparto Fisiologia Respiratoria - dip. Cardiotoracico - Ospedale Cisanello
Pisa
Spain3 sites
Hospital Vall d'Hebron de Barcelona
Barcelona, 08035
H.General de Vic, Servicio de Neumologia
Barcelona, 08500
Hospital de Matarò
Mataró, 08304
Austria2 sites
Ambulance for pediatrics and Pneumology
Vienna
Pulmologisches Zentrum Der Stadt Wien
Vienna
About this study
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.
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- beclomethasone/salbutamol combination, beclomethasone, salbutamol
- Keywords
- Anti-Asthmatic Agents, corticosteroids, symptom-driven, beclomethasone, salbutamol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasone/salbutamol combinationDrug
beclomethasoneDrug
salbutamolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
evening PEF
Diurnal variability of PEF
Nocturnal asthma (nocturnal awakening because of asthma)
Nights and days without asthma symptoms (score 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startAug 2002
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leonardo M Fabbri, MD, Principal investigator, Clinica di Malattie dell'Apparato Respiratorio, Dipartimento di Oncologia, Ematologia e Pneumologia, Università di Modena e Reggio Emilia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382889
- Sponsor's protocol ID
- MC/PR/1401/001/01
- Status last verified
- Jul 2020
- First submitted
- 29 Sep 2006
- Last updated
- 3 Aug 2020
- Results posted
- No
Publications
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.
PubMed 17507703
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00382889
- Acronym / sponsor ID
- MC/PR/1401/001/01
- Conditions
- Asthma
- Keywords
- Anti-Asthmatic Agents, corticosteroids, symptom-driven, beclomethasone, salbutamol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Sep 2004
- First posted
- 2 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beclomethasone/salbutamol combination | Drug | – |
| beclomethasone | Drug | – |
| salbutamol | Drug | – |
Primary outcome
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)
9 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Results publication: PubMed 17507703Papi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo M Fabbri, MD principal investigator
Clinica di Malattie dell'Apparato Respiratorio, Dipartimento di Oncologia, Ematologia e Pneumologia, Università di Modena e Reggio Emilia, Italy
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing beclomethasone/salbutamol combination, beclomethasone and salbutamol in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 25 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Poland, Italy, Spain, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00382889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.