Clinical trial NCT01805635: PF and FeNO and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases
Official title: Evaluation of the Relationship Between the Parameters of Pulmonary Function (PF) and the Concentration of Fractional Exhaled Nitric Oxide (FeNO) and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Allergic Rhinitis
Atopic Dermatitis
Urticaria
Healthy
Keywords: Children
Asthma
Allergic rhinitis
Atopic dermatitis
Urticaria
Healthy
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 5500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with allergic diseases, healthy children.

Brief summary: The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide level in children suspected and being diagnosed due to allergic diseases.

Detailed description: The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide (FeNO) level in children suspected and being diagnosed due to allergic diseases.

Study will be retrospective, conducted in all children diagnosed in the years of 2005-20012 in Laboratory of lung function tests of Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland. The investigators will analyse 5500 male an female children 5-18 year old suspected and being diagnosed due to allergic diseases. In these children nearly 3000 FeNO measurements, 65000 spirometry measurements, 22000 whole-body plethysmography measurements and 48000 occlusion resistance measurements were performed between the years of 2005-2012.

The investigators will retrospectively evaluate following data from medical documentation of patients:

1. FeNO levels.
2. Allergic disease diagnosis.
3. Immunoglobulin E (IgE) specific levels.
4. Treatment (drugs and dosages).
5. Lung function parameters (spirometry, whole-body plethysmography, occlusion resistance, bronchial reversibility test).

Eligibility criteria: Inclusion Criteria:

* Children with allergic diseases, healthy children.

Exclusion Criteria:

* Other serious diseases.

Primary outcomes:
measure: Allergic disease diagnosis
timeFrame: 7 years
Secondary outcomes:
measure: Lung function (LF)
timeFrame: 7 years
Other outcomes:
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: 7 years
measure: Immunoglobulin E (IgE) allergen specific
timeFrame: 7 years
measure: Treatment of asthma (drugs and dosages)
timeFrame: 7 years
Locations:
city: Lodz
country: Poland
facility: Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital
Study officials:
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
name: Iwona Stelmach, MDPhDProf
role: STUDY_CHAIR
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
name: Tomasz Grzelewski, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grzelewski T, Stelmach W, Stelmach R, Janas A, Grzelewska A, Witkowski K, Makandjou-Ola E, Majak P, Stelmach I. Spirometry-Adjusted Fraction of Exhaled Nitric Oxide Allows Asthma Diagnosis in Children, Adolescents, and Young Adults. Respir Care. 2016 Feb;61(2):162-72. doi: 10.4187/respcare.04092. Epub 2015 Dec 1.
citation: Jerzynska J, Janas A, Galica K, Stelmach W, Woicka-Kolejwa K, Stelmach I. Total specific airway resistance vs spirometry in asthma evaluation in children in a large real-life population. Ann Allergy Asthma Immunol. 2015 Oct;115(4):272-6. doi: 10.1016/j.anai.2015.07.002. Epub 2015 Jul 26.
citation: Grzelewski T, Witkowski K, Makandjou-Ola E, Grzelewska A, Majak P, Jerzynska J, Janas A, Stelmach R, Stelmach W, Stelmach I. Diagnostic value of lung function parameters and FeNO for asthma in schoolchildren in large, real-life population. Pediatr Pulmonol. 2014 Jul;49(7):632-40. doi: 10.1002/ppul.22888. Epub 2013 Sep 9.