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Small Airways Disease in Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness (AHR) (ABHR)

This study is not yet open for participant recruitment.
Verified March 2012 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
Maarten van den Berge, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01549483
First received: March 6, 2012
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to study differences in small airways (<2mm) parameters in asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.


Condition
Asthma
Airway Hyperresponsiveness

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Differences in Small Airways Disease Between Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Peripheral airway resistance measured with impulse oscillometry (IOS) [ Time Frame: visit 1 ] [ Designated as safety issue: No ]
    Difference between resistance at 5 Hz (R5) and resistance at 20 Hz (R20) (R5-20).


Secondary Outcome Measures:
  • Small airway parameters [ Time Frame: visit 1 ] [ Designated as safety issue: No ]
    Forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75), alveolar nitric oxide (NO), residual volume (RV), RV/total lung capacity (TLC)

  • mRNA expression in nasal epithelium [ Time Frame: visit 2 ] [ Designated as safety issue: No ]
  • Peripheral airway resistance measured during provocation test [ Time Frame: visit 2 ] [ Designated as safety issue: No ]
    Resistance at 5 Hz (R5) during a bronchial provocation test with methacholine


Biospecimen Retention:   Samples With DNA

Nasal epithelium brushes for mRNA expression


Estimated Enrollment: 45
Study Start Date: May 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthma
asthmatic subjects
Asymptomatic AHR
Asymptomatic subjects with airway hyperresponsiveness
Control
Healthy controls, without airway hyperresponsiveness

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Out-patient clinic

Criteria

Inclusion criteria for asymptomatic subjects with airway hyperresponsiveness (AHR) :

  • Age between 18 and 65 years.
  • Forced expiratory volume in one second (FEV1) > 80% predicted post bronchodilator.
  • Provocative concentration causing a 205 fall in FEV1 (PC20) methacholine <8 mg/ml.
  • No history of asthma or previous use of asthma medication.

Inclusion criteria for asymptomatic subjects without AHR :

  • Age between 18 and 65 years.
  • FEV1 > 80% predicted post bronchodilator.
  • PC20 methacholine >8 mg/ml.
  • No history of asthma or previous use of asthma medication.

Inclusion criteria for patients with asthma:

  • Age between 18 and 65 years.
  • FEV1 > 80% predicted.
  • PC20 methacholine ≤8 mg/ml.
  • Doctor's diagnosis of asthma.
  • No history of Chronic obstructive pulmonary disease (COPD).

Exclusion Criteria:

  • Use of inhaled or oral steroids, antihistamines, nedocromil, theophylline, leukotrien antagonists or long-acting beta-agonists for at least three weeks before the start of the study.
  • Any disease that may affect the outcome of the study as judged by the Investigator.
  • FEV1 <1.2 liter.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549483

Contacts
Contact: Maarten Van den Berge, M.D., PhD +31503616161 ext 12357 m.van.den.berge@umcg.nl
Contact: Eef D. Telenga, M.D. +31503616161 ext 19192 e.d.telenga@umcg.nl

Locations
Netherlands
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands, 9700 RB
Contact: Maarten Van den Berge, M.D., PhD     +31503616161 ext 12357     m.van.den.berge@umcg.nl    
Contact: Eef D. Telenga, M.D.     +31503616161 ext 19192     e.d.telenga@umcg.nl    
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Maarten Van den Berge, M.D., PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Maarten van den Berge, Dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01549483     History of Changes
Other Study ID Numbers: ABHR001
Study First Received: March 6, 2012
Last Updated: March 8, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
asthma
airway hyperresponsiveness
asymptomatic airway hyperresponsiveness
small airways

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

ClinicalTrials.gov processed this record on May 19, 2013