Probiotics and Capsaicin Evoked Coughs

NCT03603522 | Completed

• 1 other identifier: McMaster- DSM17938-5095
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atopic Asthma

Keywords

Cough; Capsaicin; Probiotics; TRPV1

Outcome Measures

Primary Outcomes (1)

• Emax

  The maximum number of capsaicin evoked coughs

  Day 1, Day 30, Day 59 and Day 89

Secondary Outcomes (8)

• ED50 (median effective dose)

  Day 1, Day 30, Day 59 and Day 89

• Dose response

  Day 1, Day 30, Day 59 and Day 89

• C2 and C5

  Day 1, Day 30, Day 59 and Day 89

• Responses to histamine

  Day 1, Day 30, Day 59 and Day 89

• Itch Intensity

  Day 1, Day 30, Day 59 and Day 89

Study Arms (2)

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.

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.

Dietary Supplement: BioGaia-DSM17938; Other: Placebo Comparator: Placebo Control

Interventions

BioGaia-DSM17938 DIETARY_SUPPLEMENT

2mL per day (1x10\^9 CFU) per day taken orally for 28 days

BioGaia-DSM17938 then Placebo Comparator; Placebo Comparator then BioGaia DSM17938

Placebo Comparator: Placebo Control OTHER

2mL per day of placebo formulation taken orally for 28 days

BioGaia-DSM17938 then Placebo Comparator; Placebo Comparator then BioGaia DSM17938

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• McMaster University: lead
• BioGaia AB: collaborator

Study Sites (1)

McMaster Cardio-Respiratory Research Lab

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

• 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.

  PMID: 34192396 DERIVED

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gail Gauvreau, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 27, 2018
• Study Start: July 16, 2019
• Primary Completion: January 18, 2021
• Study Completion: January 18, 2021
• Last Updated: March 26, 2021

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)