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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
April 15, 2010
April 30, 2010
July 27, 2010
April 2010
July 2010   (Final data collection date for primary outcome measure)
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO) [ Time Frame: Baseline, 4 weeks ]
Same as current
Complete list of historical versions of study NCT01113489 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Asthma
  • Allergic Rhinitis
  • Drug: beclomethasone dipropionate
    400 mcg/1 ml b.i.d.
  • Drug: placebo
    1 ml b.i.d.
  • Experimental: beclomethasone dipropionate suspension for nebulization
    Intervention: Drug: beclomethasone dipropionate
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01113489
0002565
No
Not Provided
Not Provided
Mark Gjomarkaj, National Research Council, Italy
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Not Provided
Not Provided
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP