AsthmaPhase 4NCT01642745
Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness
A Phase 4 study testing Methacholine (Provocholine) and Mannitol (Aridol) in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Methacholine (Provocholine) and Mannitol (Aridol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Feb 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable controlled asthma
Who cannot join
- pregnancy
- use of asthma therapies other than bronchodilator therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations
The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.
- Conditions
- Asthma
- Being tested
- Methacholine (Provocholine), Mannitol (Aridol)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine (Provocholine)Drug
two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL
Mannitol (Aridol)Drug
single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).
Methacholine (Provocholine)Drug
two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL every 20 seconds a deep inhalation is performed
| Study group | Role | What they receive |
|---|---|---|
| Methacholine (Provocholine) with deep inhalation | Experimental | Not described Receives: Drug: Methacholine (Provocholine) |
| Mannitol (Aridol) | Experimental | Not described Receives: Drug: Mannitol (Aridol) |
| Methacholine (Provocholine) tidal breathing | Active comparator | Not described Receives: Drug: Methacholine (Provocholine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing
The two minute tidal breathing PC20 with be captured once at visit 1.
Measured: Visit 1 (Day 1)
airway responsiveness (PD15) to inhaled mannitol
The PD15 to mannitol will be captured once at either visit 2 or visit 3.
Measured: Visit 2 = up to 13 days
Airway responsiveness (PC20) to deep inhalation methacholine
The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.
Measured: Visit 3 = up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Cockcroft, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642745
- Sponsor's protocol ID
- IIS-A-522
- Status last verified
- Oct 2016
- First submitted
- 17 Jan 2012
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Davis BE, Stewart SL, Martin AL, Cockcroft DW. Low levels of fractional exhaled nitric oxide and deep inhalation bronchoprotection are associated with mannitol non-responsiveness in asthma. Respir Med. 2014 Jun;108(6):859-64. doi: 10.1016/j.rmed.2014.03.005. Epub 2014 Mar 20.
PubMed 24702886
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations
- ClinicalTrials.gov ID
- NCT01642745
- Acronym / sponsor ID
- IIS-A-522
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Jul 2012 (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 study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methacholine (Provocholine) with deep inhalation | Experimental | Drug: Methacholine (Provocholine) |
| Mannitol (Aridol) | Experimental | Drug: Mannitol (Aridol) |
| Methacholine (Provocholine) tidal breathing | Active comparator | Drug: Methacholine (Provocholine) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable controlled asthma
Key exclusion criteria (2 listed)
- pregnancy
- use of asthma therapies other than bronchodilator therapy
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 |
|---|---|---|
| Methacholine (Provocholine)two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL | Drug | Methacholine (Provocholine) with deep inhalation |
| Mannitol (Aridol)single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg). | Drug | Mannitol (Aridol) |
| Methacholine (Provocholine)two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL every 20 seconds a deep inhalation is performed | Drug | Methacholine (Provocholine) tidal breathing |
Primary outcome
Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing
Time frame: Visit 1 (Day 1)
The two minute tidal breathing PC20 with be captured once at visit 1.
airway responsiveness (PD15) to inhaled mannitol
Time frame: Visit 2 = up to 13 days
The PD15 to mannitol will be captured once at either visit 2 or visit 3.
Airway responsiveness (PC20) to deep inhalation methacholine
Time frame: Visit 3 = up to 14 days
The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.
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 27 Oct 2016.
- Derived from this study: PubMed 24702886Davis BE, Stewart SL, Martin AL, Cockcroft DW. Low levels of fractional exhaled nitric oxide and deep inhalation bronchoprotection are associated with mannitol non-responsiveness in asthma. Respir Med. 2014 Jun;108(6):859-64. doi: 10.1016/j.rmed.2014.03.005. Epub 2014 Mar 20.
- Individual participant dataSharing planned: No
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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.
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 Methacholine (Provocholine) and Mannitol (Aridol) 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 1 inclusion and 2 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 27 Oct 2016. 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. 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?
Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing (time frame: Visit 1 (Day 1)). The study lists 3 primary outcomes in all. 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 NCT01642745, 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 27 Oct 2016.