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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113489
First Posted: April 30, 2010
Last Update Posted: July 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Change in peak expiratory flow (PEF) [ Time Frame: Baseline, 4 weeks ]
  • change in visual analogue scale score for symptoms of rhinitis [ Time Frame: Baseline, 4 weeks ]
  • change in obstructive sleep apnea syndrome score [ Time Frame: Baseline, 4 weeks ]
  • change in forced vital capacity (FVC) [ Time Frame: Baseline, 4 weeks ]
  • change in symptom scores of wheezing [ Time Frame: Baseline, 4 weeks ]
  • change in forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline, 4 weeks ]
  • change in level of IL-5 in exhaled breath condensate [ Time Frame: Baseline, 4 weeks ]

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

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mark Gjomarkaj, National Research Council, Italy
ClinicalTrials.gov Identifier: NCT01113489     History of Changes
Other Study ID Numbers: 0002565
First Submitted: April 15, 2010
First Posted: April 30, 2010
Last Update Posted: July 27, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents