AsthmaPhase 4NCT02953041
Effect of a LAMA and a uLABA on the Methacholine Dose-response Curve
A Phase 4 study testing Glycopyrronium and Indacaterol in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will assess the effects of two drugs, glycopyrronium and indacaterol, taken either as monotherapy or in combination, on the methacholine dose-response curve. This will allow for further elucidation of the mechanisms of each drug in human participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Glycopyrronium and Indacaterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to 9 Jan 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women aged 18 or older
- stable mild-to-moderate asthma
- baseline methacholine PC20 less than or equal to 8mg/mL and FEV1 greater than or equal to 65% of predicted (asthmatic participants)
- baseline methacholine PC20 greater than 16mg/mL (healthy participants)
Who cannot join
- use of long-acting bronchodilators or long-acting muscarinic antagonists within 30 days of Visit 1
- pregnant or lactating
- cardiovascular, prostate, kidney or urinary retention problems
- respiratory illness within 4 weeks of Visit 1
- allergen-induced asthma exacerbating within 4 weeks of Visit 1
- hypokalemia
Show all 9Show fewer
- diabetes
- glaucoma
- smokers and exsmokers with greater than 10 pack years
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: The Effect of Glycopyrronium and Indacaterol, as Monotherapy and in Combination, on the Methacholine Dose-response Curve
The study will assess the effects of two drugs, glycopyrronium and indacaterol, taken either as monotherapy or in combination, on the methacholine dose-response curve. This will allow for further elucidation of the mechanisms of each drug in human participants.
Read the detailed description
This will be a randomized, double-blind, three-way crossover study testing glycopyrronium (Seebri®) vs. indacaterol (Onbrez®) vs. glycopyrronium+indacaterol. The MCT method used will be the two-minute tidal breathing dosing protocol. The investigators plan to enroll thirty participants, fifteen asthmatics and fifteen non-asthmatics participants.
- Asthmatic Participants Procedure: Each participant will undergo a total of twelve MCh challenges. Each MCh challenge will be stopped when the response to MCh reaches a plateau, when the participant's FEV1 drops 40% from baseline, when the highest concentration of MCh (128mg/mL) has been administered, or if the participant wishes to stop (e.g. due to discomfort). For the purpose of this study, a plateau will be defined as the last 3 consecutive data points falling within 5%. The first day of testing will take approx. 3hrs. and will entail participants undergoing a MCh challenge to determine their baseline MCh PC20. They will then self-administer the contents of two Breezhaler inhalers. If taking one of the monotherapies, one inhaler will contain active treatment (50mcg glycopyrronium or 5mcg indacaterol) and the other inhaler will contain a placebo. For the combination treatment arm, both inhalers will contain active drug (one 50mcg glycopyrronium and one 75mcg indacaterol). The identity of the treatment administered will be unknown to the participants and to the study staff. Participants will then undergo MCT post-treatment at 1 hr., 24 hrs., and 48 hrs. Testing at 24 and 48 hrs. will take approximately 1-1.5 hrs. Therefore, participants must attend the lab at roughly the same time of day for three consecutive days for each treatment arm. Following a minimum 10-day washout between treatment administrations, the same procedure will be repeated with the second study treatment. Following a second 10-day washout, the procedure will be repeated with the third study treatment.
- Non-Asthmatic Participants Procedure: Each non-asthmatic participant will undergo a single MCh challenge, which should take approx. 1-1.5 hrs. This will allow for the generation of a "normal" MCh DRC curve to compare with the asthmatic data. The MCh challenge will be stopped when the response to MCh reaches a plateau, when the participant's FEV1 drops 40% from baseline, when the highest concentration of MCh (128mg/mL) has been administered, or if the participant wishes to stop.
- Conditions
- Asthma
- Being tested
- Glycopyrronium, Indacaterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrroniumDrug
Also called Seebri, Glycopyrrolate, Glycopyrronium bromide
long-acting muscarinic antagonist
IndacaterolDrug
Also called Onbrez
ultra long-acting beta agonist
| Study group | Role | What they receive |
|---|---|---|
| LAMA Treatment | Experimental | Inhalation of 50mcg glycopyrronium from Breezhaler device 1 hour prior to methacholine challenge Receives: Drug: Glycopyrronium |
| uLABA Treatment | Experimental | Inhalation of 75mcg indacaterol from Breezhaler device 1 hour prior to methacholine challenge Receives: Drug: Indacaterol |
| Combo Treatment | Experimental | Inhalation of 50mcg glycopyrronium from one Breezhaler device, and 75mcg indacaterol from a second Breezhaler device, all one hour prior to methacholine challenge Receives: Drug: Glycopyrronium; Drug: Indacaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline methacholine bronchoprotection at 1 hour
assessed by dose shift of geometric mean methacholine PC20 data
Measured: baseline versus 1 hour post-treatment
Secondary outcomes (2)
Change from baseline methacholine bronchoprotection at 24 hours
assessed by dose shift of geometric mean methacholine PC20 data
Measured: baseline versus 24 hours post-treatment
Change from baseline methacholine bronchoprotection at 48 hours
assessed by dose shift of geometric mean methacholine PC20 data
Measured: baseline versus 48 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completion9 Jan 2017
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 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
- NCT02953041
- Sponsor's protocol ID
- MCh-DRC-1
- Status last verified
- Jun 2017
- First submitted
- 24 Oct 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Journal Publication
Publications
Blais CM, Davis BE, Cockcroft DW. The effect of glycopyrronium and indacaterol, as monotherapy and in combination, on the methacholine dose-response curve of mild asthmatics: a randomized three-way crossover study. Respir Res. 2017 Aug 2;18(1):146. doi: 10.1186/s12931-017-0628-4.
PubMed 28768531
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glycopyrronium and Indacaterol, as Monotherapy and in Combination, on the Methacholine Dose-response Curve
- ClinicalTrials.gov ID
- NCT02953041
- Acronym / sponsor ID
- MCh-DRC-1
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 2 Nov 2016 (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 assess the effects of two drugs, glycopyrronium and indacaterol, taken either as monotherapy or in combination, on the methacholine dose-response curve. This will allow for further elucidation of the mechanisms of each drug in human participants.
Detailed description
This will be a randomized, double-blind, three-way crossover study testing glycopyrronium (Seebri®) vs. indacaterol (Onbrez®) vs. glycopyrronium+indacaterol. The MCT method used will be the two-minute tidal breathing dosing protocol. The investigators plan to enroll thirty participants, fifteen asthmatics and fifteen non-asthmatics participants.
- Asthmatic Participants Procedure: Each participant will undergo a total of twelve MCh challenges. Each MCh challenge will be stopped when the response to MCh reaches a plateau, when the participant's FEV1 drops 40% from baseline, when the highest concentration of MCh (128mg/mL) has been administered, or if the participant wishes to stop (e.g. due to discomfort). For the purpose of this study, a plateau will be defined as the last 3 consecutive data points falling within 5%. The first day of testing will take approx. 3hrs. and will entail participants undergoing a MCh challenge to determine their baseline MCh PC20. They will then self-administer the contents of two Breezhaler inhalers. If taking one of the monotherapies, one inhaler will contain active treatment (50mcg glycopyrronium or 5mcg indacaterol) and the other inhaler will contain a placebo. For the combination treatment arm, both inhalers will contain active drug (one 50mcg glycopyrronium and one 75mcg indacaterol). The identity of the treatment administered will be unknown to the participants and to the study staff. Participants will then undergo MCT post-treatment at 1 hr., 24 hrs., and 48 hrs. Testing at 24 and 48 hrs. will take approximately 1-1.5 hrs. Therefore, participants must attend the lab at roughly the same time of day for three consecutive days for each treatment arm. Following a minimum 10-day washout between treatment administrations, the same procedure will be repeated with the second study treatment. Following a second 10-day washout, the procedure will be repeated with the third study treatment.
- Non-Asthmatic Participants Procedure: Each non-asthmatic participant will undergo a single MCh challenge, which should take approx. 1-1.5 hrs. This will allow for the generation of a "normal" MCh DRC curve to compare with the asthmatic data. The MCh challenge will be stopped when the response to MCh reaches a plateau, when the participant's FEV1 drops 40% from baseline, when the highest concentration of MCh (128mg/mL) has been administered, or if the participant wishes to stop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LAMA Treatment | Experimental | Drug: GlycopyrroniumInhalation of 50mcg glycopyrronium from Breezhaler device 1 hour prior to methacholine challenge |
| uLABA Treatment | Experimental | Drug: IndacaterolInhalation of 75mcg indacaterol from Breezhaler device 1 hour prior to methacholine challenge |
| Combo Treatment | Experimental | Drug: Glycopyrronium, Drug: IndacaterolInhalation of 50mcg glycopyrronium from one Breezhaler device, and 75mcg indacaterol from a second Breezhaler device, all one hour prior to methacholine challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women aged 18 or older
- stable mild-to-moderate asthma
- baseline methacholine PC20 less than or equal to 8mg/mL and FEV1 greater than or equal to 65% of predicted (asthmatic participants)
- baseline methacholine PC20 greater than 16mg/mL (healthy participants)
Key exclusion criteria (9 listed)
- use of long-acting bronchodilators or long-acting muscarinic antagonists within 30 days of Visit 1
- pregnant or lactating
- cardiovascular, prostate, kidney or urinary retention problems
- respiratory illness within 4 weeks of Visit 1
- allergen-induced asthma exacerbating within 4 weeks of Visit 1
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 |
|---|---|---|
| GlycopyrroniumAlso: Seebri, Glycopyrrolate, Glycopyrronium bromidelong-acting muscarinic antagonist | Drug | Combo Treatment, LAMA Treatment |
| IndacaterolAlso: Onbrezultra long-acting beta agonist | Drug | Combo Treatment, uLABA Treatment |
Primary outcome
Change from baseline methacholine bronchoprotection at 1 hour
Time frame: baseline versus 1 hour post-treatment
assessed by dose shift of geometric mean methacholine PC20 data
2 secondary outcomes
Change from baseline methacholine bronchoprotection at 24 hours
Time frame: baseline versus 24 hours post-treatment
Change from baseline methacholine bronchoprotection at 48 hours
Time frame: baseline versus 48 hours post-treatment
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 14 Jun 2017.
- Derived from this study: PubMed 28768531Blais CM, Davis BE, Cockcroft DW. The effect of glycopyrronium and indacaterol, as monotherapy and in combination, on the methacholine dose-response curve of mild asthmatics: a randomized three-way crossover study. Respir Res. 2017 Aug 2;18(1):146. doi: 10.1186/s12931-017-0628-4.
- Individual participant dataSharing planned: Yes. Journal Publication
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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.
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 Glycopyrronium and Indacaterol 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 4 inclusion and 9 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 14 Jun 2017. 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?
Change from baseline methacholine bronchoprotection at 1 hour (time frame: baseline versus 1 hour post-treatment). 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 NCT02953041, 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 14 Jun 2017.