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AzTrials

Bronchial AsthmaPhase 3NCT00497523

Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms

A Phase 3 study testing Beclomethasone dipropionate, Beclomethasone dipropionate/Salbutamol combination and Salbutamol in people with Bronchial Asthma, run by Chiesi Farmaceutici S.p.A. at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation, compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young children with persistent symptoms of asthma. Read more about this study

Who is it for?
Ages 1 year to 4 years
Conditions the study is for
Bronchial Asthma
What is being tested?
Beclomethasone dipropionate, Beclomethasone dipropionate/Salbutamol combination and Salbutamol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
19 sitesin 2 countries
Study dates
Mar 2006to Jan 2007
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 1 year to 4 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients will be enrolled into the 2-week placebo run-in period if they meet all the following criteria:
  • Age ≥ 1 year and ≤ 4 years.
  • At least 3 episodes of wheeze or asthma-like symptoms in the 6 months preceding the study entry.
  • A cooperative attitude and ability to be trained to inhale correctly from the device and to complete the diary cards.
  • Written parental/guardian informed consent obtained.
  • Patients will be then randomised to the treatment period if they meet all the previous criteria plus:
  • Presence in at least 7 days out of the 14 days of the run-in period of at least one of the following symptoms: wheeze, cough or shortness of breath; or had required at least one dose of relief salbutamol.

Who cannot join

  • History of severe asthma exacerbation or exacerbations requiring hospitalisation in the previous 4 weeks.
  • Symptomatic infection of the airways requiring treatment with antibiotics or antimycotics in the previous 4 weeks.
  • Treatment with inhaled steroids in the previous 4 weeks or oral steroids in the previous 8 weeks.
  • Treatment with methyl-xantine derivatives in the previous 4 weeks.
  • Treatment with long-acting β2-agonists in the previous 2 weeks.
  • Changes in asthma medications taken on regular basis in the previous 4 weeks.
Show all 13Show fewer
  • Symptoms of asthma limited to seasonal allergen exposure.
  • History of clinically significant cardiac, renal, neurologic, hepatic, endocrine or pulmonary disease (except asthma), or laboratory testing abnormalities, whose sequelae and/or treatments can interfere with the results of the present study.
  • Evidence of pulmonary malformations.
  • Evidence of immunological deficiency (patients to be withdrawn if diagnosed during the study).
  • Cancer or any other chronic disease with prognosis < 2 years.
  • Hypersensitivity to inhaled corticosteroids.
  • Participation in another trial in the last 4 weeks.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

Ukraine13 sites

  • City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas

    Dniepropetrovsk

  • Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1

    Dniepropetrovsk

  • Department of Hospital Pediatrics, Kharkiv State Medical University Region Clinical Children's Hospital n. 2

    Kharkiv

  • Respiratory Diseases Children's Clinic, Institute of Phthisiology and Pulmonology,Academy of Medical Science of the Ukraine, Pulmonology

    Kiev

  • Children's Hospital "OHMATDYT" Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education

    Kyiv

  • Department of Clinical rehabilitation of children with bodily diseasesof Institute of Pediatrics, Obstetrics and Gynecology

    Kyiv

  • Institute of Pediatrics, Obstetrics and Gynecology. Department of Children's Pulmonology Diseases and Ecological Problems of Health

    Kyiv

  • Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children's Hospital

    Odesa

  • Poltava regional children's clinical hospital, Ukranian stomatological academy, department of pediatrics

    Poltava

  • Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children's Hospital

    Simferopol

  • Children's clinical hospital N.1, Zaporizzhya Medical Academy of post graduate education, department of pediatrics

    Zaporizhya

  • City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics

    Zaporizhya

  • Regional Children Clinical Hospital. Department of Pulmonology.

    Zaporizhya

Other trials in Ukraine

Poland6 sites

  • Zaklad Alergologii Dzieciecej

    Bialystok

  • Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy

    Krakow

  • Wojskovy Szpital Klinikzny

    Krakow

  • Priwatna Pomoc Lekarska

    Lodz

  • Alergovita, alergologia Dziecieca

    Lublin

  • Priwtny Gabinet Pediatriczno - Alergologiczny

    Rabka-Zdrój

Other trials in Poland

About this study

Official title: Double Blind, Multinational, Multicentre, Parallel-group, Placebo-controlled Design Trial of the Efficacy and Safety of Nebulised Beclometahsone Dipropionate (400 μg b.i.d.) Plus as Needed Salbutamol Versus as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination, in the 12-week Treatment of Young Children With Asthma Symptoms

To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation, compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young children with persistent symptoms of asthma.

Read the detailed description

Asthma is a chronic disease which is estimated to affect over 25 million people both in the US and Europe(i.e. approximately 10% of the total population).There is evidence that over the last 20 years prevalence has considerably increased, especially among children. The diagnosis of asthma in children may be difficult, largely because episodic wheezing and cough are among the common symptoms encountered in childhood illnesses, particularly in children under 3 years old.Although in these young children there is the possibility of over treatment, the episodes of wheezing may be reduced in intensity by the effective use of anti-inflammatory medications and bronchodilators rather than antibiotics. At present, pharmacological therapy is used to treat reversible airway obstruction, inflammation and hyperreactivity in both children and adults. Medications include preventive treatments in forms of antinflammatory/antiallergic agents (e.g. glucocorticosteroids, leukotriene antagonists, cromolyn sodium) and reliever treatments, in form of bronchodilators (e.g. β-adrenergic agonists, anticholinergics). Comparisons: Beclomethasone suspension for nebulisation (400 mcg U.D.V.) plus as needed salbutamol compared to placebo plus as needed salbutamol and to as needed salbutamol/beclomethasone fixed combination.

Being tested
Beclomethasone dipropionate, Beclomethasone dipropionate/Salbutamol combination, Salbutamol
Keywords
Asthma, Young Children, Corticosteroids, Beclomethasone, Salbutamol, Beclomethasone/Salbutamol fixed combination, Suspension for nebulisation
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beclomethasone dipropionateDrug

  • Beclomethasone dipropionate/Salbutamol combinationDrug

  • SalbutamolDrug

Study groups in NCT00497523
Study groupRoleWhat they receive
Beclomethasone dipropionateExperimentalNot described
Receives: Drug: Beclomethasone dipropionate
Beclomethasone dipropionate/Salbutamol combinationExperimentalNot described
Receives: Drug: Beclomethasone dipropionate/Salbutamol combination
SalbutamolActive comparatorNot described
Receives: Drug: Salbutamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of global (weeks 1-12) symptom-free days.

    Measured: weeks 1-12

Secondary outcomes (5)

  1. Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids)

    Measured: weeks 1-12

  2. Single clinical symptoms

    Measured: weeks 1-12 and every 2-week period

  3. Nocturnal awakening due to symptoms of asthma

    Measured: weeks 1-12 and every 2-week period

  4. Use of rescue nebulised therapy

    Measured: weeks 1-12 and every 2-week period

  5. time to first exacerbation

    Measured: weeks 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2007 (estimated)
  2. Study startMar 2006
  3. Study completionJan 2007

Resources

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
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00497523
Sponsor's protocol ID
MC/PR/1404/002/05
Status last verified
Jul 2020
First submitted
4 Jul 2007
Last updated
3 Aug 2020
Results posted
No
Data monitoring committee
No

Publications

  • Papi A, Nicolini G, Baraldi E, Boner AL, Cutrera R, Rossi GA, Fabbri LM; BEclomethasone and Salbutamol Treatment (BEST) for Children Study Group. Regular vs prn nebulized treatment in wheeze preschool children. Allergy. 2009 Oct;64(10):1463-1471. doi: 10.1111/j.1398-9995.2009.02134.x.

    PubMed 19772514

  • Papi A, Nicolini G, Boner AL, Baraldi E, Cutrera R, Fabbri LM, Rossi GA. Short term efficacy of nebulized beclomethasone in mild-to-moderate wheezing episodes in pre-school children. Ital J Pediatr. 2011 Aug 22;37:39. doi: 10.1186/1824-7288-37-39.

    PubMed 21859484

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beclomethasone dipropionate, Beclomethasone dipropionate/Salbutamol combination and Salbutamol in people with Bronchial Asthma, run by Chiesi Farmaceutici S.p.A. at 19 sites in 2 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 7 inclusion and 13 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 19 sites in Ukraine, Poland. 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?

Percentage of global (weeks 1-12) symptom-free days. (time frame: weeks 1-12). 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 NCT00497523, which also lists 2 linked publications.

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.

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