AsthmaPhase 4NCT00605410
Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness
A Phase 4 study testing ipratropium bromide in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Certain lung disease medications can influence diagnostic tests and research investigations. This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- ipratropium bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Apr 2008
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of asthma; stable and controlled
- FEV1 greater than or equal to 65% predicted
Who cannot join
- Concomitant lung disease other than asthma
Trial locations and contacts
1 site in 1 country.
About this study
Certain lung disease medications can influence diagnostic tests and research investigations. This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines.
- Conditions
- Asthma
- Being tested
- ipratropium bromide, placebo
- Keywords
- Methacholine bronchoprovocation, Antimuscarinic
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipratropium bromideDrug
Also called Atrovent HFA Inhalation Aerosol
2 puffs (40 micrograms) 2 puffs (0micrograms)
placeboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: ipratropium bromide |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
methacholine PC20
Measured: 6hours and 12 hours post inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
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.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Royal University Hospital Foundation
- Investigators
- Donald W Cockcroft, MD, Principal investigator, Department of Medicine University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605410
- Sponsor's protocol ID
- BIO 07-161
- Status last verified
- Jul 2008
- First submitted
- 18 Jan 2008
- Last updated
- 7 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Illamperuma C, Davis BE, Fenton ME, Cockcroft DW. Duration of bronchoprotection of inhaled ipratropium against inhaled methacholine. Ann Allergy Asthma Immunol. 2009 May;102(5):438-9. doi: 10.1016/S1081-1206(10)60519-4. No abstract available.
PubMed 19496252
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness
- ClinicalTrials.gov ID
- NCT00605410
- Acronym / sponsor ID
- BIO 07-161
- Conditions
- Asthma
- Keywords
- Methacholine bronchoprovocation, Antimuscarinic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Royal University Hospital Foundation
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Jan 2008 (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.
Certain lung disease medications can influence diagnostic tests and research investigations. This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ipratropium bromide |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of asthma; stable and controlled
- FEV1 greater than or equal to 65% predicted
Key exclusion criteria (1 listed)
- Concomitant lung disease other than asthma
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 |
|---|---|---|
| ipratropium bromideAlso: Atrovent HFA Inhalation Aerosol2 puffs (40 micrograms) 2 puffs (0micrograms) | Drug | 1 |
| placeboMatched placebo | Drug | 2 |
Primary outcome
methacholine PC20
Time frame: 6hours and 12 hours post inhalation
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 7 Jan 2009.
- Derived from this study: PubMed 19496252Illamperuma C, Davis BE, Fenton ME, Cockcroft DW. Duration of bronchoprotection of inhaled ipratropium against inhaled methacholine. Ann Allergy Asthma Immunol. 2009 May;102(5):438-9. doi: 10.1016/S1081-1206(10)60519-4. 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.
Donald W Cockcroft, MD principal investigator
Department of Medicine University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ipratropium bromide in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
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 2 inclusion and 1 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 7 Jan 2009. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
methacholine PC20 (time frame: 6hours and 12 hours post inhalation). 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 NCT00605410, 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 7 Jan 2009.