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MSM Product on Attenuating Nasal Provocation With a Standardized Allergenic Challenge

Primary Purpose

Nasal Breathing

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MSM
Sponsored by
Medicus Research, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nasal Breathing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers ≥ 18 and ≤ 65 years of age
  • Subjects with history of nasal congestion in response to pollen, dust mites, cat dander, and/or dog dander
  • Subjects who score "moderate" or "severe" on the VAS Nasal Symptom Score in response to an allergenic challenge at screening (V1)
  • Judged by the Investigator to be in general good health on the basis of medical history

Exclusion Criteria:

  • Pregnant and/or lactating women
  • Subjects with idiopathic rhinitis, atrophic rhinitis, or rhinitis medicamentosa

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    1g

    3g

    6g

    Arm Description

    METHYLSULFONYLMETHANE

    METHYLSULFONYLMETHANE

    METHYLSULFONYLMETHANE

    Outcomes

    Primary Outcome Measures

    Peak Nasal Inspiratory Flow (PNIF)
    VAS Nasal Symptom Score
    Number of sneezes in response to allergen exposure
    Number of used tissues in response to allergen exposure
    Weight of used tissues in response to allergen exposure

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2015
    Last Updated
    January 14, 2015
    Sponsor
    Medicus Research, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02342483
    Brief Title
    MSM Product on Attenuating Nasal Provocation With a Standardized Allergenic Challenge
    Official Title
    The Efficacy of the MSM Product on Attenuating Nasal Provocation With a Standardized Allergenic Challenge A Randomized, Double-blind, Adaptive-design Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medicus Research, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomized, double-blind, adaptive design study aims to prove that the Methylsulfonylmethane study product improves nasal breathing and "stuffy nose" symptoms after exposure to environmental allergens. Endpoints include percent change in Peak Nasal Inspiratory Flow, VAS Nasal Symptom Score, number of sneezes and number of used tissues in response to allergen exposure.
    Detailed Description
    Allergic rhinitis, or nasal allergy, is a common condition throughout the world which affects both adult and children alike. It is a group of symptoms characterized by red, itchy eyes, a blocked, itching, runny nose, rhinorrhea, and sneezing. Other reported symptoms include throat clearing, headaches, facial pain, ear pain, itchy throat and palate, snoring, and sleep disturbances. Nasal allergy commonly occurs when an individual's immune system reacts to allergens such as grass, weed, or tree pollens, house dust, mites, mold, and animal dander [1, 2]. Allergic rhinitis is considered to have a substantial effect on the quality of life of a person. Due to the significant effects it demonstrated when left untreated, the disease has gone from being labelled simply as a nuisance to being a serious illness that has to be accounted and medicated. More importantly, such illness was proven to cause asthma and sinusitis [3]. One of the popular nutritional supplements used in treating allergies such as allergic rhinitis, allergic sinusitis, inhalant allergens, and environmental allergens is Methylsulfonylmethane [4]. Methylsulfonylmethane (MSM), also known as dimethyl sulfone and methyl sulfone, is an organic compound containing sulfur that occurs naturally in a variety of fruits, vegetables, grains, and animals, including humans [5]. It is also used in treating arthritis pain, musculoskeletal pain, parasitic infections, rosacea, stretch marks, and alopecia among others [4]. The use of MSM was found to be effective in reducing symptoms of seasonal allergic rhinitis (SAR). It improves the frequency of upper respiratory signs and symptoms such as runny nose, nasal obstruction, and paroxysmal sneezing after a week of oral intake. Furthermore, few side effects were observed, but were not deemed to be of great significance. Thus, MSM was evaluated as a safe medication for SAR [6]. Likewise, MSM administration in rats displayed no adverse events or mortality. No pathological lesions or changes in organ weights were observed [4, 7]. It is proved that MSM is well tolerated in rats and can be a dietary supplement for allergies [4]. In addition, pregnant rats orally administered with MSM showed no adverse effects as well [8]. MSM can be rapidly absorbed, well distributed, and completely disposed from the body 120 hours after initial administration [9]. This randomized, double-blind, adaptive design study aims to prove that the Methylsulfonylmethane study product improves nasal breathing and "stuffy nose" symptoms after exposure to environmental allergens. Endpoints include percent change in Peak Nasal Inspiratory Flow, VAS Nasal Symptom Score, number of sneezes and number of used tissues in response to allergen exposure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasal Breathing

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1g
    Arm Type
    Active Comparator
    Arm Description
    METHYLSULFONYLMETHANE
    Arm Title
    3g
    Arm Type
    Active Comparator
    Arm Description
    METHYLSULFONYLMETHANE
    Arm Title
    6g
    Arm Type
    Active Comparator
    Arm Description
    METHYLSULFONYLMETHANE
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    MSM
    Primary Outcome Measure Information:
    Title
    Peak Nasal Inspiratory Flow (PNIF)
    Time Frame
    14 days
    Title
    VAS Nasal Symptom Score
    Time Frame
    14 days
    Title
    Number of sneezes in response to allergen exposure
    Time Frame
    14 days
    Title
    Number of used tissues in response to allergen exposure
    Time Frame
    14 days
    Title
    Weight of used tissues in response to allergen exposure
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy volunteers ≥ 18 and ≤ 65 years of age Subjects with history of nasal congestion in response to pollen, dust mites, cat dander, and/or dog dander Subjects who score "moderate" or "severe" on the VAS Nasal Symptom Score in response to an allergenic challenge at screening (V1) Judged by the Investigator to be in general good health on the basis of medical history Exclusion Criteria: Pregnant and/or lactating women Subjects with idiopathic rhinitis, atrophic rhinitis, or rhinitis medicamentosa

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30497995
    Citation
    Hewlings S, Kalman DS. Evaluating the Impacts of Methylsulfonylmethane on Allergic Rhinitis After a Standard Allergen Challenge: Randomized Double-Blind Exploratory Study. JMIR Res Protoc. 2018 Nov 29;7(11):e11139. doi: 10.2196/11139.
    Results Reference
    derived

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    MSM Product on Attenuating Nasal Provocation With a Standardized Allergenic Challenge

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