AsthmaPhase 4NCT04167280
Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma
A Phase 4 study testing Ipratropium Metered Dose Inhaler in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Ipratropium Metered Dose Inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2019to 13 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- airway responsiveness to methacholine
- adequate baseline lung function
- no respiratory infection or exposure to stimuli that may alter response to methacholine within 4 weeks
Who cannot join
- pregnancy
- current smoker
- requirement for medications other than salbutamol that will interfere with airway response to methacholine
Trial locations and contacts
1 site in 1 country.
About this study
Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.
Read the detailed description
This study is being conducted people with well controlled (mild) asthma to determine if ipratropium bromide taken three times daily for six days (i.e. 2 puffs in the morning, 2 puffs in the afternoon and 2 puffs in the evening) followed by a final dose on the morning of day 7 reduces the effectiveness of this medication on blocking the effect of methacholine challenge.
- Conditions
- Asthma
- Being tested
- Ipratropium Metered Dose Inhaler, placebo metered dose inhaler
- Keywords
- ipratropium bromide, methacholine PD20, tolerance
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium Metered Dose InhalerDrug
MDI to deliver 20mcg per puff ipratropium bromide
placebo metered dose inhalerDrug
matched MDI to deliver inactive drug
| Study group | Role | What they receive |
|---|---|---|
| Ipratropium bromide | Active comparator | 20mcg bronchodilator inhaler Receives: Drug: Ipratropium Metered Dose Inhaler |
| placebo | Placebo comparator | matching bronchodilator inhaler Receives: Drug: placebo metered dose inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine PD20
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
Measured: Pre treatment
Methacholine PD20
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
Measured: Day 7 after starting treatment
Methacholine PD20
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
Measured: 24 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start5 Nov 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
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 4
- Primary purpose
- Treatment
- 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
- Responsible party
- Principal investigator, Don Cockcroft, University of Saskatchewan
- Investigators
- Don Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167280
- Sponsor's protocol ID
- Bio REB 1522
- Status last verified
- Mar 2020
- First submitted
- 13 Nov 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma
- ClinicalTrials.gov ID
- NCT04167280
- Acronym / sponsor ID
- Bio REB 1522
- Conditions
- Asthma
- Keywords
- ipratropium bromide, methacholine PD20, tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- 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.
Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.
Detailed description
This study is being conducted people with well controlled (mild) asthma to determine if ipratropium bromide taken three times daily for six days (i.e. 2 puffs in the morning, 2 puffs in the afternoon and 2 puffs in the evening) followed by a final dose on the morning of day 7 reduces the effectiveness of this medication on blocking the effect of methacholine challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipratropium bromide | Active comparator | Drug: Ipratropium Metered Dose Inhaler20mcg bronchodilator inhaler |
| placebo | Placebo comparator | Drug: placebo metered dose inhalermatching bronchodilator inhaler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- airway responsiveness to methacholine
- adequate baseline lung function
- no respiratory infection or exposure to stimuli that may alter response to methacholine within 4 weeks
Key exclusion criteria (3 listed)
- pregnancy
- current smoker
- requirement for medications other than salbutamol that will interfere with airway response to methacholine
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 Metered Dose InhalerMDI to deliver 20mcg per puff ipratropium bromide | Drug | Ipratropium bromide |
| placebo metered dose inhalermatched MDI to deliver inactive drug | Drug | placebo |
Primary outcome
Methacholine PD20
Time frame: Pre treatment
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
Methacholine PD20
Time frame: Day 7 after starting treatment
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
Methacholine PD20
Time frame: 24 hours after last dose
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
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 26 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Don Cockcroft, MD principal investigator
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 Metered Dose Inhaler 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 3 inclusion and 3 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 26 Mar 2020. 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 PD20 (time frame: Pre treatment). 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?
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 26 Mar 2020.