AsthmaNCT00458627
Body Plethysmograph Measurements Before and After Methacholine Challenge in Early Childhood
An observational study of Asthma, run by Rambam Health Care Campus.
Trial summary
In our previous study of Methacholine Challenge Tests (MCT) in preschool children, we found that wheeze detection was associated with significant reduction in flows and vital capacity values. We hypothesized that this finding is associated with trapped-air rather than the children's loss of cooperation/concentration. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Asthma
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2.5-6.9 year-old children who were asthmatic according to GINA guidelines.
- All children previously had recurrent episodes of wheeze, cough and/or shortness of breath with clinical response to bronchodilator.
- Children were included only if they had not received anti-inflammatory medication for at least one week prior to the test or bronchodilators for at least 24 hours prior to the study.
- On the day of testing, children were included if they had normal chest auscultation and FEV1>75% predicted for healthy preschool children.
Who cannot join
- Presence of other chronic respiratory conditions
- Emergency room visit in the past three months
- Respiratory infection in the past month
About this study
In our previous study of Methacholine Challenge Tests (MCT) in preschool children, we found that wheeze detection was associated with significant reduction in flows and vital capacity values. We hypothesized that this finding is associated with trapped-air rather than the children's loss of cooperation/concentration.
Objectives: To test this hypothesis by attempting plethysmography measurements during MCT.
Read the detailed description
In young children that cannot perform adequately spirometry methacholine challenge test (MCT) is continued until any of the following clinical signals occurred: appearance of audible wheeze, a fall of >5% in O2-saturation, or an increase of >50% in respiratory rate and/or heart rate. In our previous study [1] we assessed the feasibility of determining PC20-FEV1 in relation to audible wheeze detection during MCT in asthmatic preschool children. We found that at end of test (EOT), the reduction in flows of the forced expiratory flow volume (FEFV) curves was accompanied by reduction in forced vital capacity (FVC) though reductions in flows were higher than the reduction in volume. We hypothesized that this finding is associated with trapped-air rather than the children's loss of cooperation or concentration. We have also thought that determining lung volume by whole body plethysmograpy, has the advantage of measuring airway resistance in relation to FRC. Hence, plethysmographic measurements of lung volumes during MCT may shed light on the physiological relation between airway obstruction and hyperinflation at the end of MCT when audible wheeze is detected. However, plethysmography requires the patient's cooperation and coordination to perform brief panting maneuvers against closed airways. So far, only airway resistance has been measured in the plethysmograph [10], as it is believed that young children will not comply with the occlusions needed for lung volume measurements within the plethysmograph.
The aims of the present study were twofold: a) to test if young children are capable of performing plethysmographic maneuvers required for FRC measurements; and b) to investigate if the reduction in vital capacity at maximal reduction in flows of the FEFV curves, found at wheeze detection during MCT, is due to true elevation of FRC and air trapping, or is artificially related to patients' loss of motivation/cooperation.
Methods:
Lung volumes and airway resistance will be measured in a commercial, whole body ZAN500 constant volume body plethysmograph (ZAN-Messgeraete GmbH, Germany). The plethysmograph is equipped with a graphic display for preschool children to increase cooperation. The chair can be adjusted so that the child can comfortably sit up straight with a nose-clip, and reach the mouthpiece without flexing the neck.
The plethysmography procedure will be performed according to recommendations. The test events will be explained to the child in detail outside of the plethysmograph. After that, the measurements will be carried out in the same sequence that was explained to the child. FRC will be measured by allowing for 2-3 breathing attempt series of superimposed straight lines (separated only by thermal drift). The best test out of two technically accepted series was analyzed.
MCT will be performed according to the ATS guidelines for the Methacholine Challenge Test. Tests will be performed in a designated room at the Pediatric Pulmonary Unit, Meyer Children's Hospital, Haifa, Israel. A parent and the investigating team will be present throughout the test. Tests will be performed with triple doses of fresh Methacholine solutions (0.057 to13.395 mg/ml) dissolved in saline. Solutions will be driven by a KoKo-PDS dosimeter (Ferraris Respiratory, Louisville, CO) via mouthpiece while the child was sitting upright with a nose-clip and breathing at least 10 deep breaths. Five-minute intervals will be taken between concentrations until the maximal concentration or the end point will be reached (see below). Oxygen saturation and heart-rate will be monitored continuously by pulse-oximetry (Ohmeda Biox 3700 Pulse Oximeter, USA). Auscultation for 20-seconds over the trachea and two zones of both lungs (upper front and lower back) will be performed according to recommendation. The following indices will be considered as EOT: appearance of audible wheeze, a fall of 5% in O2-saturation, or an increase of 50% in respiratory rate and/or heart rate. Nebulized Albuterol (2.5mg) was administrated after lung function measurements.
Spirometry: FEFV curves will be measured with a KoKo PDS commercial spirometer (Ferraris Respiratory, Louisville, CO), using the program incentives targets (peak expiratory flow rates or vital capacity). Calibration was performed before the testing sessions. The curves will be monitored on the computer screen to ensure best effort. On-line rejection of curves will be based on published quality control for older and preschool children including visual inspection for "non-cooperation" errors, which included poor effort, incomplete expiration, cough and glottis closure. Acceptable curves had to show a rapid rise to peak flow, and a gradual, smooth decline of flow down to residual volume.
Sequence of lung function tests: Baseline measurements included spirometry followed by plethysmography. After baseline measurements MCT will be performed. A duplicate spirometry set will be performed immediately after auscultation and during the interval between inhalations. Plethysmography will be repeated following the last spirometry at EOT and after auscultation.
- Conditions
- Asthma
- Keywords
- Plethysmograpy, preschool, methacholine challenge, spirometry, asthma
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startFeb 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Lea Bentur, MD, Principal investigator, Rambam medical Center, Haifa, IsraelDaphna Vilozni, PhD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458627
- Sponsor's protocol ID
- 2044-CTIL
- Status last verified
- Apr 2007
- First submitted
- 10 Apr 2007
- Last updated
- 11 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bentur L, Beck R, Elias N, Barak A, Efrati O, Yahav Y, Vilozni D. Methacholine bronchial provocation measured by spirometry versus wheeze detection in preschool children. BMC Pediatr. 2005 Jun 28;5:19. doi: 10.1186/1471-2431-5-19.
PubMed 15985169Vilozni D, Barak A, Efrati O, Augarten A, Springer C, Yahav Y, Bentur L. The role of computer games in measuring spirometry in healthy and "asthmatic" preschool children. Chest. 2005 Sep;128(3):1146-55. doi: 10.1378/chest.128.3.1146.
PubMed 16162700Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
PubMed 16135736Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.
PubMed 10619836
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Plethysmograph Measurements Before and After Methacholine Challenge in Early Childhood
- ClinicalTrials.gov ID
- NCT00458627
- Acronym / sponsor ID
- 2044-CTIL
- Conditions
- Asthma
- Keywords
- Plethysmograpy, preschool, methacholine challenge, spirometry, asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Sep 2006
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In our previous study of Methacholine Challenge Tests (MCT) in preschool children, we found that wheeze detection was associated with significant reduction in flows and vital capacity values. We hypothesized that this finding is associated with trapped-air rather than the children's loss of cooperation/concentration.
Objectives: To test this hypothesis by attempting plethysmography measurements during MCT.
Detailed description
In young children that cannot perform adequately spirometry methacholine challenge test (MCT) is continued until any of the following clinical signals occurred: appearance of audible wheeze, a fall of >5% in O2-saturation, or an increase of >50% in respiratory rate and/or heart rate. In our previous study [1] we assessed the feasibility of determining PC20-FEV1 in relation to audible wheeze detection during MCT in asthmatic preschool children. We found that at end of test (EOT), the reduction in flows of the forced expiratory flow volume (FEFV) curves was accompanied by reduction in forced vital capacity (FVC) though reductions in flows were higher than the reduction in volume. We hypothesized that this finding is associated with trapped-air rather than the children's loss of cooperation or concentration. We have also thought that determining lung volume by whole body plethysmograpy, has the advantage of measuring airway resistance in relation to FRC. Hence, plethysmographic measurements of lung volumes during MCT may shed light on the physiological relation between airway obstruction and hyperinflation at the end of MCT when audible wheeze is detected. However, plethysmography requires the patient's cooperation and coordination to perform brief panting maneuvers against closed airways. So far, only airway resistance has been measured in the plethysmograph [10], as it is believed that young children will not comply with the occlusions needed for lung volume measurements within the plethysmograph.
The aims of the present study were twofold: a) to test if young children are capable of performing plethysmographic maneuvers required for FRC measurements; and b) to investigate if the reduction in vital capacity at maximal reduction in flows of the FEFV curves, found at wheeze detection during MCT, is due to true elevation of FRC and air trapping, or is artificially related to patients' loss of motivation/cooperation.
Methods:
Lung volumes and airway resistance will be measured in a commercial, whole body ZAN500 constant volume body plethysmograph (ZAN-Messgeraete GmbH, Germany). The plethysmograph is equipped with a graphic display for preschool children to increase cooperation. The chair can be adjusted so that the child can comfortably sit up straight with a nose-clip, and reach the mouthpiece without flexing the neck.
The plethysmography procedure will be performed according to recommendations. The test events will be explained to the child in detail outside of the plethysmograph. After that, the measurements will be carried out in the same sequence that was explained to the child. FRC will be measured by allowing for 2-3 breathing attempt series of superimposed straight lines (separated only by thermal drift). The best test out of two technically accepted series was analyzed.
MCT will be performed according to the ATS guidelines for the Methacholine Challenge Test. Tests will be performed in a designated room at the Pediatric Pulmonary Unit, Meyer Children's Hospital, Haifa, Israel. A parent and the investigating team will be present throughout the test. Tests will be performed with triple doses of fresh Methacholine solutions (0.057 to13.395 mg/ml) dissolved in saline. Solutions will be driven by a KoKo-PDS dosimeter (Ferraris Respiratory, Louisville, CO) via mouthpiece while the child was sitting upright with a nose-clip and breathing at least 10 deep breaths. Five-minute intervals will be taken between concentrations until the maximal concentration or the end point will be reached (see below). Oxygen saturation and heart-rate will be monitored continuously by pulse-oximetry (Ohmeda Biox 3700 Pulse Oximeter, USA). Auscultation for 20-seconds over the trachea and two zones of both lungs (upper front and lower back) will be performed according to recommendation. The following indices will be considered as EOT: appearance of audible wheeze, a fall of 5% in O2-saturation, or an increase of 50% in respiratory rate and/or heart rate. Nebulized Albuterol (2.5mg) was administrated after lung function measurements.
Spirometry: FEFV curves will be measured with a KoKo PDS commercial spirometer (Ferraris Respiratory, Louisville, CO), using the program incentives targets (peak expiratory flow rates or vital capacity). Calibration was performed before the testing sessions. The curves will be monitored on the computer screen to ensure best effort. On-line rejection of curves will be based on published quality control for older and preschool children including visual inspection for "non-cooperation" errors, which included poor effort, incomplete expiration, cough and glottis closure. Acceptable curves had to show a rapid rise to peak flow, and a gradual, smooth decline of flow down to residual volume.
Sequence of lung function tests: Baseline measurements included spirometry followed by plethysmography. After baseline measurements MCT will be performed. A duplicate spirometry set will be performed immediately after auscultation and during the interval between inhalations. Plethysmography will be repeated following the last spirometry at EOT and after auscultation.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 2.5-6.9 year-old children who were asthmatic according to GINA guidelines.
- All children previously had recurrent episodes of wheeze, cough and/or shortness of breath with clinical response to bronchodilator.
- Children were included only if they had not received anti-inflammatory medication for at least one week prior to the test or bronchodilators for at least 24 hours prior to the study.
- On the day of testing, children were included if they had normal chest auscultation and FEV1>75% predicted for healthy preschool children.
Key exclusion criteria (3 listed)
- Presence of other chronic respiratory conditions
- Emergency room visit in the past three months
- Respiratory infection in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2007.
- Background: PubMed 15985169Bentur L, Beck R, Elias N, Barak A, Efrati O, Yahav Y, Vilozni D. Methacholine bronchial provocation measured by spirometry versus wheeze detection in preschool children. BMC Pediatr. 2005 Jun 28;5:19. doi: 10.1186/1471-2431-5-19.
- Background: PubMed 16162700Vilozni D, Barak A, Efrati O, Augarten A, Springer C, Yahav Y, Bentur L. The role of computer games in measuring spirometry in healthy and "asthmatic" preschool children. Chest. 2005 Sep;128(3):1146-55. doi: 10.1378/chest.128.3.1146.
- Background: PubMed 16135736Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
- Background: PubMed 10619836Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Bentur, MD principal investigator
Rambam medical Center, Haifa, Israel
Daphna Vilozni, PhD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458627, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2007.