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

This study has been completed.
Sponsor:
Information provided by:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier:
NCT01113489
First received: April 15, 2010
Last updated: July 26, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Asthma
Allergic Rhinitis
Drug: beclomethasone dipropionate
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone

Resource links provided by NLM:


Further study details as provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

Primary Outcome Measures:
  • Change in level of oral and nasal fractional exhaled nitric oxide (FeNO) [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in peak expiratory flow (PEF) [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • change in visual analogue scale score for symptoms of rhinitis [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • change in obstructive sleep apnea syndrome score [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • change in forced vital capacity (FVC) [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • change in symptom scores of wheezing [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • change in forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • change in level of IL-5 in exhaled breath condensate [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: beclomethasone dipropionate suspension for nebulization Drug: beclomethasone dipropionate
400 mcg/1 ml b.i.d.
Placebo Comparator: placebo Drug: placebo
1 ml b.i.d.

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113489

Locations
Italy
Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)
Palermo, Italy, 90146
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  More Information

No publications provided

Responsible Party: Mark Gjomarkaj, National Research Council, Italy
ClinicalTrials.gov Identifier: NCT01113489     History of Changes
Other Study ID Numbers: 0002565
Study First Received: April 15, 2010
Last Updated: July 26, 2010
Health Authority: Italy: National Bioethics Committee

Additional relevant MeSH terms:
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014