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OpenTrials
Completed

NCT Number: NCT01549483

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Peripheral airway resistance measured with impulse oscillometry (IOS)

    Time frame: visit 1

    Difference between resistance at 5 Hz (R5) and resistance at 20 Hz (R20) (R5-20).

Secondary outcomes

  1. Small airway parameters

    Time frame: visit 1

    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)

  2. mRNA expression in nasal epithelium

    Time frame: visit 2

  3. Peripheral airway resistance measured during provocation test

    Time frame: visit 2

    Resistance at 5 Hz (R5) during a bronchial provocation test with methacholine

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Differences in Small Airways Disease Between Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness

Acronym: ABHR

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2012
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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