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Different End Points for Bronchial Hyperactivity (BHR) Tests.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01654588
First Posted: August 1, 2012
Last Update Posted: December 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avigdor Mandelberg, Wolfson Medical Center
  Purpose

Bronchial challenge tests (BCT) are being used to diagnose bronchial hyperactivity (BHR) and quantify its severity.In older children and adults, BCT is done using spirometry to measure the value of 20% fall in FEV1 as an indicator for positive reactivity.

However, in young children and infants that cannot perform spirometry, other measurements are used as indicators for BHR. Traditionally, in these populations, appearance of wheezing on auscultation is used as the indicator for BHR. More recently, other measures like 50% increase in respiratory rate or 5% decreases in oxygen saturation are mentioned as possible options to determine positive BHR. Nevertheless, as these measurements probably measure different parameters they could vary in time of appearance.

The investigators also noted that in older children who perform spirometry, the order of appearance of these different physiologic measures is not constant.

Decrease in O2 saturation, appearance of wheezing and increase in respiratory rate (RR) do not all appear at the same time and not in the same order of events.

Some children are noted to have a decrease in FEV1 without wheezing - those children can be difficult to diagnose as asthmatics in the primary care setting where asthma is being diagnosed on clinical grounds alone: wheezing and response to bronchodilators. Children who do not wheeze are difficult to diagnose and therefore, are not getting the appropriate treatment.

Nevertheless, the data in current literature is very scant or not existing regarding these issues. Thus the investigators designed a study to prospectively try to answer the questions: do clinically significant differences exist in the concentration of the metacholine and / or adenosine at the time time of appearances of these parameters, what comes first, and if so, how does it affect the diagnosis and the severity assessment of HRA in different age groups?


Condition
Bronchial Hyperreactivity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Different End Points for Bronchial Hyperactivity (BHR) Tests, What Comes First?

Further study details as provided by Avigdor Mandelberg, Wolfson Medical Center:

Primary Outcome Measures:
  • Which of the outcome ends points measures comes first in the diagnosis of bronchial hypersensitiveness. [ Time Frame: On which metacholine and / or adenosine increasing concentrations, there are 20% fall in FEV1 and / or 5% decrease in saturation and / or 50% increase in RR. Which comes first. Time frame: each BHR tests last up to two hours. ]
    Increasing concentrations of Metacholine or adenosine inhalations are given until there are 20% fall in FEV1 and / or 5% decrease in saturation and / or 50% increase in RR. The concentrations on which these outcomes occur are measured.


Secondary Outcome Measures:
  • Age influence on which comes first outcomes. [ Time Frame: The time frame of the study: four years. ]
    Age in years and months will be recorded. Age influence on the distribution of the main outcome - which comes first - will be calculated.


Enrollment: 501
Study Start Date: September 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Bronchial challenge tests (BCT) are being used to diagnose bronchial hyperactivity (BHR) and quantify its severity.

In older children and adults, BCT is done using spirometry to measure the value of 20% fall in FEV1 as an indicator for positive reactivity. However, in young children and infants that cannot perform spirometry, other measurements are used as indicators for BHR. Traditionally, in these populations, appearance of wheezing on auscultation is used as the indicator for BHR. More recently, other measures like 50% increase in respiratory rate or 5% decreases in oxygen saturation are mentioned as possible options to determine positive BHR. Nevertheless, as these measurements probably measure different parameters they could vary in time of appearance.

The investigators also noted that in older children who perform spirometry, the order of appearance of these different physiologic measures is not constant.

Decrease in O2 saturation, appearance of wheezing and increase in respiratory rate (RR) do not all appear at the same time and not in the same order of events.

Some children are noted to have a decrease in FEV1 without wheezing - those children can be difficult to diagnose as asthmatics in the primary care setting where asthma is being diagnosed on clinical grounds alone: wheezing and response to bronchodilators. Children who do not wheeze are difficult to diagnose and therefore, are not getting the appropriate treatment.

Nevertheless, the data in current literature is very scant or not existing regarding these issues. Thus the investigators designed a study to prospectively try to answer the questions: do clinically significant differences exist in the time of appearances of these parameters and if so, how does it affect the diagnosis and the severity assessment of HRA in different age groups? in this study we measure the metacholine and / or adenosine concentration at the time when the following parameters appear (what comes first): 20% fall in FEV1, 5% fall in oxygen saturation, 50% rise in respiratory rate, wheezing heard by the investigators using stethoscope.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred for HRA trigger testing.
Criteria

Inclusion Criteria:

  • Patients referred for HRA trigger testing

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654588


Locations
Israel
The Edith Wlofson Medical Center
Holon, Israel
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Avigdor Madnelberg, MD The Sackler School of Medicine, Tel-Aviv University, Israel
Principal Investigator: Avigdor Mandelberg, MD Tha Sackler School of Medicine, Tel-Aviv University, Israel
  More Information

Responsible Party: Avigdor Mandelberg, Director, Pediatric Pulmonry Unit, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01654588     History of Changes
Other Study ID Numbers: AD-S
First Submitted: July 26, 2011
First Posted: August 1, 2012
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Avigdor Mandelberg, Wolfson Medical Center:
BRONCHIAL CHALLANGE TEST, ASTHMA, METACHLINE, ADENOSINE

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases