AsthmaPhase 2NCT00557700
Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma
A Phase 2 study testing Administration of inhaled tiotropium bromide in people with Asthma, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Administration of inhaled tiotropium bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2008to May 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Male or female, at least 18 years old
- Documented medical history of asthma (diagnosis at least 6 months ago)
- Non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
- Able to conduct a technically acceptable spirometry, methacholine and neurokinin-A provocation test.
- At visit 1: PC20 methacholine ≤ 8 mg/ml AND ≤ 3.3x10-7 mol/ml for the neurokinin-A provocation test.
- At visit 1: forced expiratory value in one second >= 80% of the predicted value.
- Female subjects may not get pregnant and should be using adequate contraception.
Who cannot join
- Airway infection within 6 weeks prior to first study visit.
- Other respiratory diseases (eg COPD, lung cancer, etc.)
- Participating in another clinical trial.
- Clinically relevant systemic diseases, other than asthma.
- Clinically significant laboratory deviations.
- Alcohol or drug abuse.
- Female subjects who are lactating.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Ghent
Ghent, 9000
CHU Sart Tilman ULG
Liège, 4000
About this study
This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.
- Conditions
- Asthma
- Being tested
- Administration of inhaled tiotropium bromide, Administration of placebo
- Keywords
- Mild to moderate asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of inhaled tiotropium bromideDrug
Administration of inhaled tiotropium bromide
Administration of placeboDrug
Administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Administration of placebo Receives: Drug: Administration of placebo |
| 1 | Experimental | Administration of inhaled tiotropium bromide Receives: Drug: Administration of inhaled tiotropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in the provocative concentration of neurokinin-A (NKA) causing a 20% fall in the forced expiratory volume in one second (PC20NKA), as a measure of indirect airway hyperresponsiveness
Measured: After 20 days
Secondary outcomes (2)
The change in the one-second-value in the forced vital capacity
Measured: After 20 days
The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness
Measured: After 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionMay 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.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Investigators
- Guy Joos, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557700
- Sponsor's protocol ID
- 2007/378
- Status last verified
- Jun 2010
- First submitted
- 12 Nov 2007
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma
- ClinicalTrials.gov ID
- NCT00557700
- Acronym / sponsor ID
- 2007/378
- Conditions
- Asthma
- Keywords
- Mild to moderate asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Nov 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 trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Administration of placeboAdministration of placebo |
| 1 | Experimental | Drug: Administration of inhaled tiotropium bromideAdministration of inhaled tiotropium bromide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent
- Male or female, at least 18 years old
- Documented medical history of asthma (diagnosis at least 6 months ago)
- Non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
- Able to conduct a technically acceptable spirometry, methacholine and neurokinin-A provocation test.
Key exclusion criteria (7 listed)
- Airway infection within 6 weeks prior to first study visit.
- Other respiratory diseases (eg COPD, lung cancer, etc.)
- Participating in another clinical trial.
- Clinically relevant systemic diseases, other than asthma.
- Clinically significant laboratory deviations.
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 |
|---|---|---|
| Administration of inhaled tiotropium bromideAdministration of inhaled tiotropium bromide | Drug | 1 |
| Administration of placeboAdministration of placebo | Drug | 2 |
Primary outcome
The mean change in the provocative concentration of neurokinin-A (NKA) causing a 20% fall in the forced expiratory volume in one second (PC20NKA), as a measure of indirect airway hyperresponsiveness
Time frame: After 20 days
2 secondary outcomes
The change in the one-second-value in the forced vital capacity
Time frame: After 20 days
The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness
Time frame: After 20 days
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 16 Jun 2010.
- Website University Hospital GhentLink 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.
Guy Joos, MD, PhD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of inhaled tiotropium bromide in people with Asthma, run by University Hospital, Ghent at 2 sites in Belgium.
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 7 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 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The mean change in the provocative concentration of neurokinin-A (NKA) causing a 20% fall in the forced expiratory volume in one second (PC20NKA), as a measure of indirect airway hyperresponsiveness (time frame: After 20 days). 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 16 Jun 2010.