Nasal Breathing Clinical Trial
Official title:
The Efficacy of the MSM Product on Attenuating Nasal Provocation With a Standardized Allergenic Challenge A Randomized, Double-blind, Adaptive-design Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03400787 -
Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse
|
N/A |