AsthmaNCT01095627
Characterization of Aerosol Generation and Transport in the Human Lung
A study testing Metacholine challenge in people with Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine.
Trial summary
This study is aiming at evaluating whether the number and size of exhaled particles changes during the increase and decrease of bronchial constriction in subjects with mild intermittent asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Metacholine challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jun 2010
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged 18 to 65 years.
- Physician diagnosis of mild intermittent allergic asthma (GINA I according to GINA guidelines9).
- Normal lung function parameters at baseline (FEV1 > 80 % of predicted)
- Non smoker or smokers with a history of less than 10 pack years with no smoking in the last 12 months.
- Able and willing to give written informed consent
- Women will be considered for inclusion if they are:
- not pregnant, as confirmed by pregnancy test, and not nursing of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit) of childbearing potential and using a highly effective method of contraception during the entire study (vasectomized partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the study until at least 72 hours after the end of the study -, implants, injectables, combined oral contraceptives, hormonal IUDs, or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap)
- Available to complete all study measurements
Who cannot join
- History of lower respiratory tract infection four weeks prior to the informed consent visit.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements, and short acting beta mimetics (SABA) on as needed basis.
- Use of anti-inflammatory medication including systemic or inhaled corticosteroid within the last four weeks.
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
- Conditions or factors, which would make the subject unlikely to be able to undergo methacholine challenge.
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- Conditions which provide a contraindication for methacholine challenge testing such as uncontrolled arterial hypertension, known aortic aneurysm, myocardial infarction or stroke within three months prior to study, current use of cholinesterase inhibitor medication.
- Inability to perform acceptable-quality spirometry.
- History of drug or alcohol abuse.
- Participation in another clinical trial 30 days prior to enrolment.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- Risk of non-compliance with study procedures.
About this study
Official title: Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Mild Intermittent Allergic Asthma Before and After Methacholine Challenge
This study is aiming at evaluating whether the number and size of exhaled particles changes during the increase and decrease of bronchial constriction in subjects with mild intermittent asthma.
Read the detailed description
Particle emission demonstrates high reproducibility within subjects while between-subject-variability is large. Methacholine challenge in subjects with mild intermittent asthma will provide data from repetitive measurements in the same subject with variable airflow obstruction.
- Conditions
- Asthma
- Being tested
- Metacholine challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacholine challengeOther
Exhaled breath analysis following metacholine challenge
| Study group | Role | What they receive |
|---|---|---|
| Metacholine Challenge | Other | Exhaled breath analysis following metacholine challenge Receives: Other: Metacholine challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled breath analysis
In ten subjects with mild intermittent allergic asthma particles in exhaled breath will be analyzed for their number and size in a time dependent manner before and after induction of bronchial obstruction by methacholine challenge.
Measured: Within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095627
- Sponsor's protocol ID
- 10/04 AEROB
- Status last verified
- Feb 2011
- First submitted
- 12 Mar 2010
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Mild Intermittent Allergic Asthma Before and After Methacholine Challenge
- ClinicalTrials.gov ID
- NCT01095627
- Acronym / sponsor ID
- 10/04 AEROB
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Mar 2010 (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 aiming at evaluating whether the number and size of exhaled particles changes during the increase and decrease of bronchial constriction in subjects with mild intermittent asthma.
Detailed description
Particle emission demonstrates high reproducibility within subjects while between-subject-variability is large. Methacholine challenge in subjects with mild intermittent asthma will provide data from repetitive measurements in the same subject with variable airflow obstruction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metacholine Challenge | Other | Other: Metacholine challengeExhaled breath analysis following metacholine challenge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects, aged 18 to 65 years.
- Physician diagnosis of mild intermittent allergic asthma (GINA I according to GINA guidelines9).
- Normal lung function parameters at baseline (FEV1 > 80 % of predicted)
- Non smoker or smokers with a history of less than 10 pack years with no smoking in the last 12 months.
- Able and willing to give written informed consent
Key exclusion criteria (12 listed)
- History of lower respiratory tract infection four weeks prior to the informed consent visit.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements, and short acting beta mimetics (SABA) on as needed basis.
- Use of anti-inflammatory medication including systemic or inhaled corticosteroid within the last four weeks.
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
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 |
|---|---|---|
| Metacholine challengeExhaled breath analysis following metacholine challenge | Other | Metacholine Challenge |
Primary outcome
Exhaled breath analysis
Time frame: Within one day
In ten subjects with mild intermittent allergic asthma particles in exhaled breath will be analyzed for their number and size in a time dependent manner before and after induction of bronchial obstruction by methacholine challenge.
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 9 Feb 2011.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Metacholine challenge in people with Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine.
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 8 inclusion and 12 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 9 Feb 2011. 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.
What does the primary outcome measure?
Exhaled breath analysis (time frame: Within one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2011.