Different End Points for Bronchial Hyperactivity (BHR) Tests.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Wolfson Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Avigdor Mandelberg, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01654588
First received: July 26, 2011
Last updated: July 28, 2012
Last verified: July 2012
  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 Wolfson Medical Center:

Primary Outcome Measures:
  • Which of the outcome ends points measures comes first in the diagnosis of BHR. [ 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. ] [ Designated as safety issue: No ]
    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: two years. ] [ Designated as safety issue: No ]
    Age in years and months will be recorded. Age influence on the distribution of the main outcome - which comes first - will be calculated.


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   1 Month to 80 Years
Genders Eligible for Study:   Both
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:

  • None
  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: NCT01654588

Contacts
Contact: Avigdor Mandelberg, MD 972-522-2786000 avigdorm@netvision.net.il

Locations
Israel
The Edith Wlofson Medical Center Recruiting
Holon, Israel
Contact: Avigdor Mandelberg, MD    972-522-786000    avigdorm@netvision.net.il   
Principal Investigator: Avigdor Mandelberg, MD         
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

No publications provided

Responsible Party: Avigdor Mandelberg, Director, Pediatric Pulmonry Unit, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01654588     History of Changes
Other Study ID Numbers: AD-S
Study First Received: July 26, 2011
Last Updated: July 28, 2012
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Wolfson Medical Center:
BHR, METACHLINE, ADENOSINE, RR, SATURATION, WHEEZING

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Hyperkinesis
Bronchial Diseases
Respiratory Tract Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014