Atopic AsthmaPCECNCT03603522
Probiotics and Capsaicin Evoked Coughs
A study testing BioGaia-DSM17938 in people with Atopic Asthma, run by McMaster University at 1 site in Canada.
Trial summary
Cough in asthma is a very common and troublesome symptom in asthma, which predicts severity and poor prognosis. Previous studies have shown that asthmatics have an exaggerated cough response to capsaicin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Asthma
- What is being tested?
- BioGaia-DSM17938
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2019to 18 Jan 2021
- Phase
- Interventional
- 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
- Aged ≥18
- Able to understand and give written informed consent
- Has a diagnosis of atopic asthma (based on at least one positive skin prick test and Methacholine PC20 ≤16 mg/ml)
- FEV1 (forced expiratory volume at 1 second) ≥ 70% of predicted
- Demonstrate a cough response to capsaicin
Who cannot join
- Subjects who are in a pollen season that affects their asthma
- Subjects who bronchoconstrict by more than 10% at the end of the full dose capsaicin cough challenge (assess after visit 1)
- Subjects who do not display evidence of airway hyper-responsiveness (PC20>16mg/ml) (assess after visit 1)
- Symptoms of upper respiratory tract infection (URTI) in the last 1 month which have not resolved.
- Lower respiratory tract infection or pneumonia in the last 6 weeks.
- Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6 months
Show all 15Show fewer
- Asthma exacerbation in the previous month requiring an increase or start of an ICS (inhaled corticosteroids) or OCS (oral corticosteroids)
- Any asthma medication with the exception of infrequent (less than twice weekly) short-acting beta-agonist.
- Subjects who have changed asthma medication within the past 4 weeks prior to screening
- A previous asthma exacerbation requiring Intensive Care Unit (ICU) admission.
- Significant other primary pulmonary disorders in particularly; pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis.
- Pregnancy or breast-feeding
- Use of ACE (angiotensin converting enzyme) inhibitors
- Any centrally acting medication which in the view of the investigator could alter the sensitivity of the cough reflex
- History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster Cardio-Respiratory Research Lab
Hamilton, Ontario, L8N 3Z5
About this study
Official title: A Double-Blind Randomized Placebo Controlled Trial Investigating the Effects of DSM17938 on Capsaicin Evoked Coughs
Cough in asthma is a very common and troublesome symptom in asthma, which predicts severity and poor prognosis. Previous studies have shown that asthmatics have an exaggerated cough response to capsaicin. Currently available asthma treatment is not designed to target the cough reflex directly, so this presents an unmet need for patients. The treatment being tested in this study is the commercially available over the counter oral probiotic BioGaia® DSM17938. Based on clinical and pre-clinical evidence, it is hypothesized that TRPV1 antagonism with BioGaia® DSM17938 will result in a reduction in capsaicin evoked coughs in patients with asthma.
Read the detailed description
Visit 1: Baseline Screening and Beginning of Treatment Period 1 Subjects will undergo consent, complete history, physical examination, spirometry, capsaicin cough challenge, skin prick testing (allergen and histamine), methacholine challenge, induced sputum and blood sampling. Eligible subjects will then be randomized with matched oral BioGaia DSM17938 and placebo and will be given for the next 4 weeks.
Visit 2: End of Treatment Period 1 Subjects will undergo spirometry, capsaicin cough challenge, skin prick testing, methacholine challenge, sputum induction and blood testing.
Washout: 28 day washout period prior to Visit 3.
Visit 3: Beginning of Treatment Period 2 Subjects wills undergo all the same tests performed in visit 2. Drug/Placebo will be given for the next 28 days.
Visit 4: End of Treatment Period 2 Subjects will undergo all the same tests performed in visit 2.
- Conditions
- Atopic Asthma
- Being tested
- BioGaia-DSM17938, Placebo Comparator: Placebo Control
- Keywords
- Cough, Capsaicin, Probiotics, TRPV1
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioGaia-DSM17938Dietary supplement
2mL per day (1x10^9 CFU) per day taken orally for 28 days
Placebo Comparator: Placebo ControlOther
2mL per day of placebo formulation taken orally for 28 days
| Study group | Role | What they receive |
|---|---|---|
| BioGaia-DSM17938 then Placebo Comparator | Experimental | 28 days treatment with BioGaia-DSM17938, followed by 28 days washout and then crossover to 28 days placebo comparator treatment. Receives: Dietary Supplement: BioGaia-DSM17938; Other: Placebo Comparator: Placebo Control |
| Placebo Comparator then BioGaia DSM17938 | Placebo comparator | 28 days treatment with placebo comparator treatment, followed by 28 days washout and then crossover to 28 days treatment with BioGaia DSM17938. Receives: Dietary Supplement: BioGaia-DSM17938; Other: Placebo Comparator: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emax
The maximum number of capsaicin evoked coughs
Measured: Day 1, Day 30, Day 59 and Day 89
Secondary outcomes (8)
ED50 (median effective dose)
The dose of capsaicin that evokes at least half the maximum number of coughs
Measured: Day 1, Day 30, Day 59 and Day 89
Dose response
Changes in the capsaicin full dose response curves
Measured: Day 1, Day 30, Day 59 and Day 89
C2 and C5
Changes in the dose of capsaicin causing 2 coughs (C2) and 5 coughs (C5)
Measured: Day 1, Day 30, Day 59 and Day 89
Responses to histamine
The wheal responses to graded doses of histamine skin prick testing
Measured: Day 1, Day 30, Day 59 and Day 89
Itch Intensity
The intensity of itch after skin prick testing using a modified Borg scale (0-10)
Measured: Day 1, Day 30, Day 59 and Day 89
T-Cell Cytokine
Inhibition of T-Cell cytokine responses to stimulation in blood
Measured: Day 1, Day 30, Day 59 and Day 89
Sputum differential cell counts
Changes in sputum differential cell counts
Measured: Day 1, Day 30, Day 59 and Day 89
PC20
Changes in methacholine PC20
Measured: Day 1, Day 30. Day 59 and Day 89
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start16 Jul 2019
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
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 Atopic AsthmaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will have a screening period followed by 28 days treatment with BioGaia DSM17938 or placebo, followed by a washout period and will then crossover to the opposite treatment received in the first part of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Sponsor
- Investigators
- Gail Gauvreau, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603522
- Sponsor's protocol ID
- McMaster- DSM17938-5095
- Acronym
- PCEC
- Status last verified
- Mar 2019
- First submitted
- 18 Jul 2018
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Satia I, Cusack R, Stevens C, Schlatman A, Wattie J, Mian F, Killian KJ, O'Byrne PM, Bienenstock J, Forsythe P, Gauvreau GM. Limosilactobacillus reuteri DSM-17938 for preventing cough in adults with mild allergic asthma: A double-blind randomized placebo-controlled cross-over study. Clin Exp Allergy. 2021 Sep;51(9):1133-1143. doi: 10.1111/cea.13976. Epub 2021 Jul 8.
PubMed 34192396
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Placebo Controlled Trial Investigating the Effects of DSM17938 on Capsaicin Evoked Coughs
- ClinicalTrials.gov ID
- NCT03603522
- Acronym / sponsor ID
- PCEC / McMaster- DSM17938-5095
- Conditions
- Atopic Asthma
- Keywords
- Cough, Capsaicin, Probiotics, TRPV1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 27 Jul 2018 (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.
Cough in asthma is a very common and troublesome symptom in asthma, which predicts severity and poor prognosis. Previous studies have shown that asthmatics have an exaggerated cough response to capsaicin. Currently available asthma treatment is not designed to target the cough reflex directly, so this presents an unmet need for patients. The treatment being tested in this study is the commercially available over the counter oral probiotic BioGaia® DSM17938. Based on clinical and pre-clinical evidence, it is hypothesized that TRPV1 antagonism with BioGaia® DSM17938 will result in a reduction in capsaicin evoked coughs in patients with asthma.
Detailed description
Visit 1: Baseline Screening and Beginning of Treatment Period 1 Subjects will undergo consent, complete history, physical examination, spirometry, capsaicin cough challenge, skin prick testing (allergen and histamine), methacholine challenge, induced sputum and blood sampling. Eligible subjects will then be randomized with matched oral BioGaia DSM17938 and placebo and will be given for the next 4 weeks.
Visit 2: End of Treatment Period 1 Subjects will undergo spirometry, capsaicin cough challenge, skin prick testing, methacholine challenge, sputum induction and blood testing.
Washout: 28 day washout period prior to Visit 3.
Visit 3: Beginning of Treatment Period 2 Subjects wills undergo all the same tests performed in visit 2. Drug/Placebo will be given for the next 28 days.
Visit 4: End of Treatment Period 2 Subjects will undergo all the same tests performed in visit 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will have a screening period followed by 28 days treatment with BioGaia DSM17938 or placebo, followed by a washout period and will then crossover to the opposite treatment received in the first part of the study.
| Arm | Type | Receives |
|---|---|---|
| BioGaia-DSM17938 then Placebo Comparator | Experimental | Dietary Supplement: BioGaia-DSM17938, Other: Placebo Comparator: Placebo Control28 days treatment with BioGaia-DSM17938, followed by 28 days washout and then crossover to 28 days placebo comparator treatment. |
| Placebo Comparator then BioGaia DSM17938 | Placebo comparator | Dietary Supplement: BioGaia-DSM17938, Other: Placebo Comparator: Placebo Control28 days treatment with placebo comparator treatment, followed by 28 days washout and then crossover to 28 days treatment with BioGaia DSM17938. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18
- Able to understand and give written informed consent
- Has a diagnosis of atopic asthma (based on at least one positive skin prick test and Methacholine PC20 ≤16 mg/ml)
- FEV1 (forced expiratory volume at 1 second) ≥ 70% of predicted
- Demonstrate a cough response to capsaicin
Key exclusion criteria (15 listed)
- Subjects who are in a pollen season that affects their asthma
- Subjects who bronchoconstrict by more than 10% at the end of the full dose capsaicin cough challenge (assess after visit 1)
- Subjects who do not display evidence of airway hyper-responsiveness (PC20>16mg/ml) (assess after visit 1)
- Symptoms of upper respiratory tract infection (URTI) in the last 1 month which have not resolved.
- Lower respiratory tract infection or pneumonia in the last 6 weeks.
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 |
|---|---|---|
| BioGaia-DSM179382mL per day (1x10^9 CFU) per day taken orally for 28 days | Dietary supplement | BioGaia-DSM17938 then Placebo Comparator, Placebo Comparator then BioGaia DSM17938 |
| Placebo Comparator: Placebo Control2mL per day of placebo formulation taken orally for 28 days | Other | BioGaia-DSM17938 then Placebo Comparator, Placebo Comparator then BioGaia DSM17938 |
Primary outcome
Emax
Time frame: Day 1, Day 30, Day 59 and Day 89
The maximum number of capsaicin evoked coughs
8 secondary outcomes
ED50 (median effective dose)
Time frame: Day 1, Day 30, Day 59 and Day 89
Dose response
Time frame: Day 1, Day 30, Day 59 and Day 89
C2 and C5
Time frame: Day 1, Day 30, Day 59 and Day 89
Responses to histamine
Time frame: Day 1, Day 30, Day 59 and Day 89
Itch Intensity
Time frame: Day 1, Day 30, Day 59 and Day 89
T-Cell Cytokine
Time frame: Day 1, Day 30, Day 59 and Day 89
Sputum differential cell counts
Time frame: Day 1, Day 30, Day 59 and Day 89
PC20
Time frame: Day 1, Day 30. Day 59 and Day 89
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 2021.
- Derived from this study: PubMed 34192396Satia I, Cusack R, Stevens C, Schlatman A, Wattie J, Mian F, Killian KJ, O'Byrne PM, Bienenstock J, Forsythe P, Gauvreau GM. Limosilactobacillus reuteri DSM-17938 for preventing cough in adults with mild allergic asthma: A double-blind randomized placebo-controlled cross-over study. Clin Exp Allergy. 2021 Sep;51(9):1133-1143. doi: 10.1111/cea.13976. Epub 2021 Jul 8.
- 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.
Gail Gauvreau, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioGaia-DSM17938 in people with Atopic Asthma, run by McMaster University 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 5 inclusion and 15 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 2021. 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.
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?
Emax (time frame: Day 1, Day 30, Day 59 and Day 89). 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 NCT03603522, 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 26 Mar 2021.