NCT00952835

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4.4 years

First QC Date

August 3, 2009

Last Update Submit

June 18, 2013

Conditions

Keywords

AsthmarhinitisEIBExhaled Nitric oxidelung functionvitamin d

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

asthma and rhinitis control

Other: regular treatment

Interventions

regular treatment

Also known as: asthma treatment
asthma and rhinitis control

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • patient with asthma and rhinitis

You may not qualify if:

  • age \<5 years
  • chronic respiratory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric department University of Verona

Verona, Verona, 37134, Italy

RECRUITING

Related Publications (2)

  • Chinellato I, Piazza M, Peroni D, Sandri M, Chiorazzo F, Boner AL, Piacentini G. Bronchial and alveolar nitric oxide in exercise-induced bronchoconstriction in asthmatic children. Clin Exp Allergy. 2012 Aug;42(8):1190-6. doi: 10.1111/j.1365-2222.2012.03973.x.

  • Peroni DG, Cattazzo E, Chinellato I, Piazza M, Tezza G, Boner AL, Piacentini GL. Nasal mucosa temperature as a marker of disease in children with allergic rhinitis. Am J Rhinol Allergy. 2012 Jul-Aug;26(4):e115-8. doi: 10.2500/ajra.2012.26.3803.

MeSH Terms

Conditions

AsthmaRhinitis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfectionsNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Attilio Boner, MD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Attilio Boner, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
full professor

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 6, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations