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

About this trial
This is an interventional supportive care trial for Nasal Breathing
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
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
NCT ID
NCT02342483
First Posted
January 14, 2015
Last Updated
January 14, 2015
Sponsor
Medicus Research, LLC
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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