Bronchial HyperreactivityNCT00503659
Comparison of Two Methods of Bronchial Methacholine Provocation
A study testing Bronchial methacholine provocation in people with Bronchial Hyperreactivity and Bronchial Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
This study is meant to compare two routine diagnostic approaches in patients with bronchial asthma. Patients are challenged with methacholine in order to measure their bronchial response. We compare the evaluation of the effects of incremental concentrations versus incremental dosages. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Hyperreactivity, Bronchial Asthma
- What is being tested?
- Bronchial methacholine provocation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Dec 2007
- Phase
- Interventional
- 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 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Informed consent
- Age 12-45 years
- Known bronchial hyperreactivity
Who cannot join
- Age < 12 > 45 years
- Clinical asthma requiring regular inhalation
- Vital capacity < 80%
- FEV1 < 75%
- Chronic disease conditions or infections
- Pregnancy
Show all 9Show fewer
- Inhalative or systemic steroid use
- Substance abuse
- Incapability of understanding the study's purpose and performance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, 60590
About this study
Official title: Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1
This study is meant to compare two routine diagnostic approaches in patients with bronchial asthma. Patients are challenged with methacholine in order to measure their bronchial response. We compare the evaluation of the effects of incremental concentrations versus incremental dosages.
Read the detailed description
Bronchial methacholine challenge is well established in asthma diagnostic and research purposes. ATS guidelines provide a short five-breath dosimeter protocol using a five-step dilution schedule. The Viasys APS system enables a feasible and less time consuming provocation with incremental dosages. In 48 young adults with bronchial hyperreactivity (BHR) the ATS-protocol with a five-step protocol using a single dilution of 16 mg/ml methacholine should be compared.
- Conditions
- Bronchial Hyperreactivity, Bronchial Asthma
- Being tested
- Bronchial methacholine provocation
- Keywords
- PC20 FEV1, PD20FEV1, bronchial hyperreactivity, bronchial asthma
- Medical subject headings
- Bronchial Hyperreactivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial methacholine provocationProcedure or surgery
Also called DeVilbiss nebulizer
A short five-breath dosimeter protocol using a five-step dilution schedule according to ATS guidelines (0.0625, 0.25, 1, 4, 16 mg/ml methacholine)
Bronchial methacholine provocationProcedure or surgery
Also called Viasys APS nebulizer
A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Methacholine challenge, five-breath dosimeter protocol Receives: Procedure: Bronchial methacholine provocation |
| B | Active comparator | Methacholine challenge five incremental dosages protocol Receives: Procedure: Bronchial methacholine provocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of the two parameters PC20 FEV1 and PD20 FEV1
Measured: feb 2007 - dec 2007
Secondary outcomes (1)
kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration
Measured: see above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial HyperreactivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Schulze MD, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, M.D., Ph.D., Principal investigator, Goethe University, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503659
- Sponsor's protocol ID
- 335/06/FFM
- Status last verified
- Oct 2011
- First submitted
- 18 Jul 2007
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crapo 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 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1
- ClinicalTrials.gov ID
- NCT00503659
- Acronym / sponsor ID
- 335/06/FFM
- Conditions
- Bronchial Hyperreactivity, Bronchial Asthma
- Keywords
- PC20 FEV1, PD20FEV1, bronchial hyperreactivity, bronchial asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Jul 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.
This study is meant to compare two routine diagnostic approaches in patients with bronchial asthma. Patients are challenged with methacholine in order to measure their bronchial response. We compare the evaluation of the effects of incremental concentrations versus incremental dosages.
Detailed description
Bronchial methacholine challenge is well established in asthma diagnostic and research purposes. ATS guidelines provide a short five-breath dosimeter protocol using a five-step dilution schedule. The Viasys APS system enables a feasible and less time consuming provocation with incremental dosages. In 48 young adults with bronchial hyperreactivity (BHR) the ATS-protocol with a five-step protocol using a single dilution of 16 mg/ml methacholine should be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Bronchial methacholine provocationMethacholine challenge, five-breath dosimeter protocol |
| B | Active comparator | Procedure: Bronchial methacholine provocationMethacholine challenge five incremental dosages protocol |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Informed consent
- Age 12-45 years
- Known bronchial hyperreactivity
Key exclusion criteria (9 listed)
- Age < 12 > 45 years
- Clinical asthma requiring regular inhalation
- Vital capacity < 80%
- FEV1 < 75%
- Chronic disease conditions or infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchial methacholine provocationAlso: DeVilbiss nebulizerA short five-breath dosimeter protocol using a five-step dilution schedule according to ATS guidelines (0.0625, 0.25, 1, 4, 16 mg/ml methacholine) | Procedure or surgery | A |
| Bronchial methacholine provocationAlso: Viasys APS nebulizerA five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg) | Procedure or surgery | B |
Primary outcome
correlation of the two parameters PC20 FEV1 and PD20 FEV1
Time frame: feb 2007 - dec 2007
1 secondary outcome
kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration
Time frame: see above
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 12 Oct 2011.
- 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.
Stefan Zielen, M.D., Ph.D. principal investigator
Goethe University, Department of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial methacholine provocation in people with Bronchial Hyperreactivity and Bronchial Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 3 inclusion and 9 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 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
correlation of the two parameters PC20 FEV1 and PD20 FEV1 (time frame: feb 2007 - dec 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00503659, which also lists 1 linked publication.
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 12 Oct 2011.