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

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:

MedlinePlus related topics: Asthma

Drug Information available for: Beclomethasone dipropionate Beclomethasone dipropionate monohydrate

U.S. FDA Resources

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

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:

Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections

Otorhinolaryngologic Diseases
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 May 16, 2013