Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Universita di Verona
Sponsor:
Collaborator:
Azienda Ospedaliera Universitaria Policlinico
Information provided by (Responsible Party):
Boner Attilio, Universita di Verona
ClinicalTrials.gov Identifier:
NCT00952835
First received: August 3, 2009
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

In this study will be consecutive enrolled children with asthma (classified according to GINA guidelines) and rhinitis (classified by ARIA guidelines); the investigators will research clinical personal and parental history regarding allergic diseases, exposition to passive smoking and interpretate hematochemical parameters markers of atopy. Skin Prick Tests will be performed. In this study the investigators will evaluate lung function parameters (spirometry with bronchial reversibility test and exercise induced bronchoconstriction, oscillometry, respiratory plethysmography, etc.), airway inflammatory indices such as exhaled nitric oxide at different flows, exhaled and nasal temperature, nasal cytology.

The aim of the study will be to evaluate possible correlation between these different parameters and clinical status of the patients.


Condition Intervention
Asthma
Rhinitis
Other: regular treatment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis [ Time Frame: Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
asthma and rhinitis control Other: regular treatment
regular treatment
Other Name: asthma treatment

Detailed Description:

Each patients will be evaluated by spirometry and then he will undergo exercise challenge in order to evaluate exercise-induced bronchoconstriction as a marker of asthma control. The test of the challenge will be correlate with childhood Asthma control test score,levels of control (GINA classification)and the different markers of airway inflammation and atopy.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

children with asthma and/or rhinitis visited at the outpatients clinic at the University of Verona will be invited to participate to the study

Criteria

Inclusion Criteria:

  • patient with asthma and rhinitis

Exclusion Criteria:

  • age <5 years
  • chronic respiratory diseases
  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: NCT00952835

Contacts
Contact: Attilio Boner, MD --390458124615 attilio.boner@univr.it

Locations
Italy
Pediatric department University of Verona Recruiting
Verona, Italy, 37134
Contact: Attilio Boner, MD    --390458124615    attilio.boner@univr.it   
Principal Investigator: Attilio Boner, MD         
Sub-Investigator: Iolanda Chinellato, MD         
Sponsors and Collaborators
Universita di Verona
Azienda Ospedaliera Universitaria Policlinico
Investigators
Principal Investigator: Attilio Boner, MD Universita di Verona
  More Information

No publications provided by Universita di Verona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boner Attilio, full professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT00952835     History of Changes
Other Study ID Numbers: AOV-1716
Study First Received: August 3, 2009
Last Updated: June 18, 2013
Health Authority: Italy: National Bioethics Committee

Keywords provided by Universita di Verona:
Asthma
rhinitis
EIB
Exhaled Nitric oxide
lung function
vitamin d

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

ClinicalTrials.gov processed this record on July 20, 2014