Different End Points for Bronchial Hyperactivity (BHR) Tests.

NCT01654588 | Completed

• 1 other identifier: AD-S
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Bronchial Hyperreactivity

Keywords

BRONCHIAL CHALLANGE TEST, ASTHMA, METACHLINE, ADENOSINE

Outcome Measures

Primary Outcomes (1)

• Which of the outcome ends points measures comes first in the diagnosis of bronchial hypersensitiveness.

  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.

  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.

Secondary Outcomes (1)

• Age influence on which comes first outcomes.

  The time frame of the study: four years.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients referred for HRA trigger testing.

You may qualify if:

• Patients referred for HRA trigger testing

You may not qualify if:

• None

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

The Edith Wlofson Medical Center

Holon, Israel

Location

Related Publications (1)

• Ater D, Amirav I, Attias M, Nakash E, Newhouse MT, Mandelberg A. Evaluation of clinically and physiologically atypical asthma: If it doesn't wheeze it may still be asthma. J Asthma. 2019 Jan;56(1):21-26. doi: 10.1080/02770903.2018.1424194. Epub 2018 Feb 2.

  PMID: 29393720 DERIVED

MeSH Terms

Conditions

Bronchial Hyperreactivity; Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Pulmonry Unit

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 1, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

IL (1)