AsthmaNCT00491153
Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist
An observational study of Asthma, run by St. Olavs Hospital at 3 sites in Norway.
Trial summary
The purpose of this study is to estimate the sensitivity, specificity and positive and negative predictive values of a positive Aridol challenge with respect to a specialist pulmonologist diagnosis of asthma in corticosteroid naive subjects with asthma-like symptoms and no previous diagnosis of asthma. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Asthma
- How many people
- 35 participants
- Where
- 3 sitesNorway
- Study dates
- Sep 2007to Dec 2012
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with a tentative diagnosis of asthma or suspected asthma referred to a pulmonologist for evaluation
Who may be able to join
- Informed consent
- Provisional or possible asthma diagnosis
- FEV1 at least 70% of predicted at inclusion
Who cannot join
- Contraindications for bronchial provocation challenge or spirometry
- Respiratory tract infection within previous 6 weeks
- Significant co-morbidity
- > 10 pack year smoking history
- Other lung diseases
- Pregnancy, lactation
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Haukeland University Hospital
Bergen
St.Olavs Hospital, University Hospital of Trondheim
Trondheim, South Trøndelag, N-7006
Dr Alf Magne Heggli medical practice
Trondheim, South Trøndelag
About this study
The purpose of this study is to estimate the sensitivity, specificity and positive and negative predictive values of a positive Aridol challenge with respect to a specialist pulmonologist diagnosis of asthma in corticosteroid naive subjects with asthma-like symptoms and no previous diagnosis of asthma. The comparator is methacholine provocation
- Conditions
- Asthma
- Keywords
- asthma, airway hyperresponsiveness, dry powder mannitol inhalation, methacholine
- Medical subject headings
- Asthma, Respiratory Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test
with respect to asthma diagnosis by a specialist pulmonary physician in corticosteroid-naïve subjects presenting with signs and symptoms suggestive of asthma but without a definitive diagnosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: due to low recruitment rate secondary to very stringent inclusion criteria
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 AsthmaStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Ernst Omenaas, MD, PhD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491153
- Sponsor's protocol ID
- 4.2006.3606(REK)
- Other IDs
- 2006-006469-17
- Status last verified
- Dec 2013
- First submitted
- 22 Jun 2007
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10(1):4. doi: 10.1186/1465-9921-10-4.
PubMed 19161635
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist
- ClinicalTrials.gov ID
- NCT00491153
- Acronym / sponsor ID
- 4.2006.3606(REK)
- Conditions
- Asthma
- Keywords
- asthma, airway hyperresponsiveness, dry powder mannitol inhalation, methacholine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to low recruitment rate secondary to very stringent inclusion criteria
- Enrolment
- 35 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Sep 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Jun 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.
The purpose of this study is to estimate the sensitivity, specificity and positive and negative predictive values of a positive Aridol challenge with respect to a specialist pulmonologist diagnosis of asthma in corticosteroid naive subjects with asthma-like symptoms and no previous diagnosis of asthma. The comparator is methacholine provocation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with a tentative diagnosis of asthma or suspected asthma referred to a pulmonologist for evaluation
Key inclusion criteria (3 listed)
- Informed consent
- Provisional or possible asthma diagnosis
- FEV1 at least 70% of predicted at inclusion
Key exclusion criteria (6 listed)
- Contraindications for bronchial provocation challenge or spirometry
- Respiratory tract infection within previous 6 weeks
- Significant co-morbidity
- > 10 pack year smoking history
- Other lung diseases
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
sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test
Time frame: 1 day
with respect to asthma diagnosis by a specialist pulmonary physician in corticosteroid-naïve subjects presenting with signs and symptoms suggestive of asthma but without a definitive diagnosis.
Results and safety
The study was stopped early (reason given: due to low recruitment rate secondary to very stringent inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Background: PubMed 19161635Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10(1):4. doi: 10.1186/1465-9921-10-4.
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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.
Ernst Omenaas, MD, PhD study director
Haukeland University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by St. Olavs Hospital at 3 sites in Norway.
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 6 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: stopped early, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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 was stopped early (reason given: due to low recruitment rate secondary to very stringent inclusion criteria). Results are not available in the source record.
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?
sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test (time frame: 1 day). 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 NCT00491153, 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 19 Dec 2013.