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

NCT01113489 | Completed Phase 3

• 1 other identifier: 0002565
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 4 weeks

Secondary Outcomes (7)

• Change in peak expiratory flow (PEF)

  Baseline, 4 weeks

• change in visual analogue scale score for symptoms of rhinitis

  Baseline, 4 weeks

• change in obstructive sleep apnea syndrome score

  Baseline, 4 weeks

• change in forced vital capacity (FVC)

  Baseline, 4 weeks

• change in symptom scores of wheezing

  Baseline, 4 weeks

Study Arms (2)

beclomethasone dipropionate suspension for nebulization

EXPERIMENTAL

Drug: beclomethasone dipropionate

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

beclomethasone dipropionate DRUG

400 mcg/1 ml b.i.d.

beclomethasone dipropionate suspension for nebulization

placebo DRUG

1 ml b.i.d.

placebo

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children with intermittent asthma and allergic rhinitis

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Palermo, 90146, Italy

Location

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 30, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 27, 2010

Record last verified: 2010-05

Locations

IT (1)