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

Condition(s) targeted: Bronchial Asthma

Intervention: Beclomethasone dipropionate (Drug); Beclomethasone dipropionate/Salbutamol combination (Drug); Salbutamol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Chiesi Farmaceutici S.p.A.

Official(s) and/or principal investigator(s):
Renato Cutrera, MD, Study Chair, Affiliation: Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

Single clinical symptoms

Nocturnal awakening due to symptoms of asthma

Use of rescue nebulised therapy

time to first exacerbation

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.

Minimum age: 1 Year. Maximum age: 4 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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.

Exclusion Criteria:

- 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.

- 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.

Priwtny Gabinet Pediatriczno – Alergologiczny, Rabka Zdroj, Poland

Wojskovy Szpital Klinikzny, Krakow, Poland

Alergovita, alergologia Dziecieca, Lublin, Poland

Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy, Krakow, Poland

Priwatna Pomoc Lekarska, Lodz, Poland

Zaklad Alergologii Dzieciecej, Bialystok, Poland

Children’s Hospital “OHMATDYT” Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education, Kyiv, Ukraine

Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children’s Hospital, Odessa, Ukraine

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

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

Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children’s Hospital, Simferopol, Ukraine

Institute of Pediatrics, Obstetrics and Gynecology. Department of Children’s Pulmonology Diseases and Ecological Problems of Health, Kyiv, Ukraine

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

Regional Children Clinical Hospital. Department of Pulmonology., Zaporizhya, Ukraine

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

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

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

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

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

Starting date: March 2006
Ending date: January 2007
Last updated: July 5, 2007