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Completed

NCT Number: NCT02381158

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

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.

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Key information

Conditions

Wheezing Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • one parent with asthma
  • Atopic Dermatitis
  • sensibilisation to air allergen

Secondary:

  • Food sensibilization
  • wheezing also not during the infective episodes
  • 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

Treatment and study plan

Nebulized beclomethasone dipropionate

Drug

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

Other names: BDP

Primary outcomes

  1. Lung fuction with Rint and FOT

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2015
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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