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| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioGaia-DSM17938 | Dietary Supplement | 2mL per day (1x10^9 CFU) per day taken orally for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Emax | The maximum number of capsaicin evoked coughs | Day 1, Day 30, Day 59 and Day 89 |
| Measure | Description | Time Frame |
|---|---|---|
| ED50 (median effective dose) | The dose of capsaicin that evokes at least half the maximum number of coughs | Day 1, Day 30, Day 59 and Day 89 |
| Dose response | Changes in the capsaicin full dose response curves |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Gauvreau, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Cardio-Respiratory Research Lab | Hamilton | Ontario | L8N 3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34192396 | Derived | 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. |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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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.
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| Placebo Comparator: Placebo Control | Other | 2mL per day of placebo formulation taken orally for 28 days |
|
| 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) | Day 1, Day 30, Day 59 and Day 89 |
| Responses to histamine | The wheal responses to graded doses of histamine skin prick testing | 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) | Day 1, Day 30, Day 59 and Day 89 |
| T-Cell Cytokine | Inhibition of T-Cell cytokine responses to stimulation in blood | Day 1, Day 30, Day 59 and Day 89 |
| Sputum differential cell counts | Changes in sputum differential cell counts | Day 1, Day 30, Day 59 and Day 89 |
| PC20 | Changes in methacholine PC20 | Day 1, Day 30. Day 59 and Day 89 |
| D013568 | Pathological Conditions, Signs and Symptoms |