NCT02342483

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

1 month

First QC Date

January 14, 2015

Last Update Submit

January 14, 2015

Conditions

Nasal Breathing

Outcome Measures

Primary Outcomes (5)

  • Peak Nasal Inspiratory Flow (PNIF)

    14 days

  • VAS Nasal Symptom Score

    14 days

  • Number of sneezes in response to allergen exposure

    14 days

  • Number of used tissues in response to allergen exposure

    14 days

  • Weight of used tissues in response to allergen exposure

    14 days

Study Arms (3)

1g

ACTIVE COMPARATOR

METHYLSULFONYLMETHANE

Dietary Supplement: MSM

3g

ACTIVE COMPARATOR

METHYLSULFONYLMETHANE

Dietary Supplement: MSM

6g

ACTIVE COMPARATOR

METHYLSULFONYLMETHANE

Dietary Supplement: MSM

Interventions

MSMDIETARY_SUPPLEMENT
1g3g6g

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30497995DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 21, 2015

Study Start

July 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 21, 2015

Record last verified: 2015-01