Cell Distribution in Induced Sputum in Patients With Asthma

NCT ID: NCT01543516

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-06-30

Brief Summary

The aim of this case-control study is the comparison of the cell distribution in induced sputum in young adults with asthma and in healthy controls.

The study consists of two visits. At both visits subjects are asked to perform a lung function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured. At the first visit a blood sample is drawn to determine the inflammatory and allergic status of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit another sputum sample is induced by a nozzle nebulizer. The cell distribution will be evaluated in both sputum samples.

Detailed Description

Objectives:

The aim of this study is the characterization of healthy children/ young adults and matched patients with asthma in terms of lung function, and the degree of the systemic and bronchial inflammation.

Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by a cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are determined from sputum or blood respectively.

Methods and Work Programme:

This study consists of two study visits (V1 and V2)

V1 (day 0 - duration 1 hour):

• Measurement of exhaled nitric oxide (eNO)
• Lung function testing with and body plethysmography
• Blood test: blood count, CRP, RAST, serum inflammatory mediators, markers of the non-specific pulmonary defense system
• Induced sputum attained by an ultrasonic-nebulizer for inflammatory mediators and microbiological investigations

V2 (day 14-28 - duration 1 hour):

• Measurement of nitric oxide in expired air (eNO)
• Lung function testing with spirometry and body plethysmography
• Induced sputum attained by a nozzle-nebulizer for inflammatory mediators and microbiological investigations

Study population:

Children, adolescents and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.

Conditions

Bronchial Asthma With eNO-levels Greater Than 30 ppB

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with Asthma

Affected patients

-20 Patients suffering from asthma with an eNO over 30 bbp

No interventions assigned to this group

Healthy Subjects

Non-affected patients

-20 matched controls not suffering from asthma

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• informed consent
• between 6 and 25 years of age
• Known bronchial asthma/no bronchial asthma(depending on the study group)
• Ability to perform lung function tests and inhalation

Exclusion Criteria

• < 6 and > 25 years of age
• Any acute condition with systemic or bronchial inflammation
• any chronic condition or infection (e.g. HIV, tuberculosis, malignancy)
• pregnancy
• known alcohol and/ or drug abuse
• Inability to understand the extent and scope of the study
• Participation in another study

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Martin Rosewich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital, Goethe-University

Frankfurt am Main, Hesse, Germany

Countries

Germany

References

Koc-Gunel S, Schubert R, Zielen S, Rosewich M. Cell distribution and cytokine levels in induced sputum from healthy subjects and patients with asthma after using different nebulizer techniques. BMC Pulm Med. 2018 Jul 13;18(1):115. doi: 10.1186/s12890-018-0683-8.

Reference Type: DERIVED

PMID: 30005648 (View on PubMed)

Other Identifiers

FRA-AKAS

Identifier Type: -

Identifier Source: org_study_id