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OpenTrials
Completed

NCT Number: NCT01113489

Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone

Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)

Palermo, 90146, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children with intermittent asthma and allergic rhinitis

Exclusion criteria

  • children with acute respiratory symptoms in the last 4 weeks
  • children with nasal polyposis or bronchial or respiratory tract infections
  • children with a severe exacerbation of asthma resulting in hospitalization during the last month

Treatment and study plan

Beclomethasone dipropionate

Drug

400 mcg/1 ml b.i.d.

Placebo

Drug

1 ml b.i.d.

Primary outcomes

  1. Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)

    Time frame: Baseline, 4 weeks

Secondary outcomes

  1. Change in peak expiratory flow (PEF)

    Time frame: Baseline, 4 weeks

  2. change in visual analogue scale score for symptoms of rhinitis

    Time frame: Baseline, 4 weeks

  3. change in obstructive sleep apnea syndrome score

    Time frame: Baseline, 4 weeks

  4. change in forced vital capacity (FVC)

    Time frame: Baseline, 4 weeks

  5. change in symptom scores of wheezing

    Time frame: Baseline, 4 weeks

  6. change in forced expiratory volume in 1 second (FEV1)

    Time frame: Baseline, 4 weeks

  7. change in level of IL-5 in exhaled breath condensate

    Time frame: Baseline, 4 weeks

Sponsors and collaborators

Lead sponsor

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2010
Registry last updated
Jul 27, 2010

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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