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

Sponsor

Chiesi Farmaceutici S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT00497523

Collaborator

(none)

283

Enrollment

Locations

Arms

10.1

Duration (Months)

14.9

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bronchial Asthma	Drug: Beclomethasone dipropionate Drug: Beclomethasone dipropionate/Salbutamol combination Drug: Salbutamol	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

283 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2006

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Beclomethasone dipropionate	Drug: Beclomethasone dipropionate
Experimental: Beclomethasone dipropionate/Salbutamol combination	Drug: Beclomethasone dipropionate/Salbutamol combination
Active Comparator: Salbutamol	Drug: Salbutamol

Arm

Intervention/Treatment

Experimental: Beclomethasone dipropionate

Drug: Beclomethasone dipropionate

Experimental: Beclomethasone dipropionate/Salbutamol combination

Drug: Beclomethasone dipropionate/Salbutamol combination

Active Comparator: Salbutamol

Drug: Salbutamol

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids) [weeks 1-12]
Single clinical symptoms [weeks 1-12 and every 2-week period]
Nocturnal awakening due to symptoms of asthma [weeks 1-12 and every 2-week period]
Use of rescue nebulised therapy [weeks 1-12 and every 2-week period]
time to first exacerbation [weeks 1-12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Zaklad Alergologii Dzieciecej	Bialystok	Poland
2	Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy	Krakow	Poland
3	Wojskovy Szpital Klinikzny	Krakow	Poland
4	Priwatna Pomoc Lekarska	Lodz	Poland
5	Alergovita, alergologia Dziecieca	Lublin	Poland
6	Priwtny Gabinet Pediatriczno - Alergologiczny	Rabka Zdroj	Poland
7	City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas	Dniepropetrovsk	Ukraine
8	Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1	Dniepropetrovsk	Ukraine
9	Department of Hospital Pediatrics, Kharkiv State Medical University Region Clinical Children's Hospital n. 2	Kharkiv	Ukraine
10	Respiratory Diseases Children's Clinic, Institute of Phthisiology and Pulmonology,Academy of Medical Science of the Ukraine, Pulmonology	Kiev	Ukraine
11	Children's Hospital "OHMATDYT" Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education	Kyiv	Ukraine
12	Department of Clinical rehabilitation of children with bodily diseasesof Institute of Pediatrics, Obstetrics and Gynecology	Kyiv	Ukraine
13	Institute of Pediatrics, Obstetrics and Gynecology. Department of Children's Pulmonology Diseases and Ecological Problems of Health	Kyiv	Ukraine
14	Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children's Hospital	Odessa	Ukraine
15	Poltava regional children's clinical hospital, Ukranian stomatological academy, department of pediatrics	Poltava	Ukraine
16	Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children's Hospital	Simferopol	Ukraine
17	Children's clinical hospital N.1, Zaporizzhya Medical Academy of post graduate education, department of pediatrics	Zaporizhya	Ukraine
18	City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics	Zaporizhya	Ukraine
19	Regional Children Clinical Hospital. Department of Pulmonology.	Zaporizhya	Ukraine