Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing

Wheezing Clinical Trial

Official title:

Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381158
• Other study ID #: 0000573
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2015
• Last updated: January 19, 2017
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of symptoms and exacerbations, will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• Informed and subscribed consent before any procedure

• Age range : 2 - =5 years

• Male and female patients

• Recurrent wheezing affected ( = 4 episodes in the last 12 months)

• PAI positive (at least one primary and two secondary ):

Primary:

1. one parent with asthma

2. Atopic Dermatitis

3. sensibilisation to air allergen

Secondary:

1. Food sensibilization

2. wheezing also not during the infective episodes

3. eosinophilia (>4%)

Exclusion Criteria:

• story of severe wheeze requiring hospitalization

• treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks

• structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc)

• Persistent infections

• aspiration lung disease (gastroesophageal reflux disease, etc.)

• Cystic fibrosis

• prematurity or bronchopulmonary dysplasia

• Tuberculosis

• primary ciliary dyskinesia

• congenital heart disease

• pulmonary foreign body

• bronchiectasis

• Immunodeficit

Related Conditions & MeSH terms

• Respiratory Sounds
• Wheezing

Intervention

Drug:
• Nebulized beclomethasone dipropionate
Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung fuction with Rint and FOT		12 Weeks