Cell Distribution in Induced Sputum in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01543516
First received: February 20, 2012
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition
Bronchial Asthma With eNO-levels Greater Than 30 ppB

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cell Distribution in Induced Sputum in Healthy Subjects and Patients With Asthma After Different Techniques for Sputum Induction

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • cell count differences in induced sputum [ Time Frame: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour) ] [ Designated as safety issue: No ]
    Differences in neutrophils, macrophages and lymphocytes in subjects with and without asthma


Secondary Outcome Measures:
  • differences in cell count depending on the method of sputum induction [ Time Frame: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour) ] [ Designated as safety issue: No ]
    At V1 an ultrasonic nebulizer is used for sputum induction. At V2 a breath controlled nozzle nebulizer is used for sputum induction. These different techniques might lead to different cell counts in included subjects.


Biospecimen Retention:   Samples With DNA

whole blood, serum, and sputum


Enrollment: 40
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Asthma

Affected patients

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

Healthy Subjects

Non-affected patients

-20 matched controls not suffering from asthma


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.

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study is carried out in children, adolescents, and young adults (6 to 25 years of age). Both the patients (n=20) and the healthy subjects (n=20) are recruited from the outpatient clinic of the department of Pediatric Allergy and Pulmonology, University Clinic, Goethe-University, Frankfurt/M, Germany.

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
  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: NCT01543516

Locations
Germany
Children's Hospital, Goethe-University
Frankfurt am Main, Hessen, Germany, 60596
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01543516     History of Changes
Other Study ID Numbers: FRA-AKAS
Study First Received: February 20, 2012
Last Updated: June 29, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Asthma
Sputum
Blood
Inflammation
adaptive immune system
innate immune system

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014