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

This study has been completed.
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: January 15, 2015
Last verified: January 2015

March 6, 2012
January 15, 2015
May 2012
May 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01549483 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Small Airways Disease in Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness (AHR)
Differences in Small Airways Disease Between Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Nasal epithelium brushes for mRNA expression
Non-Probability Sample
Out-patient clinic
  • Asthma
  • Airway Hyperresponsiveness
Not Provided
  • Asthma
    asthmatic subjects
  • Asymptomatic AHR
    Asymptomatic subjects with airway hyperresponsiveness
  • Control
    Healthy controls, without airway hyperresponsiveness
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
June 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01549483
ABHR001
No
Not Provided
Not Provided
Maarten van den Berge, University Medical Centre Groningen
University Medical Center Groningen
Not Provided
Principal Investigator: Maarten Van den Berge, M.D., PhD University Medical Center Groningen
University Medical Center Groningen
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP