Investigation of the ability of MRI to show changes in the nose after treatment of patients with Vicks® Sinex® Micromist®

• Conditions: MedDRA version: 13.1Level: PTClassification code 10028735Term: Nasal congestionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; asal Congestion due to the common cold or hay fever; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2011-002443-10-GB
• Lead Sponsor: Procter & Gamble Technical Centres Ltd., UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-14
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Subjects meeting all of the following criteria will be considered for admission to this study:

a)have provided written informed consent;
b)are generally healthy by report and review of medication/medical history;
c)are at least 18 years of age and not older than 65 years of age, inclusive, at screening;
d)report suffering from nasal congestion due to common cold or hay fever;
e)rate the severity of their nasal congestion as either a 2=Moderate (definite awareness of sign/symptom that is bothersome but tolerable) or 3=Severe (sign/symptom that is hard to tolerate) on the Nasal Congestion Severity Scale (Section 3.4.2.1);
f)if female and of child-bearing potential, have practiced abstinence or used an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 3 months before being enrolled in the study;
g)have a body mass index (BMI) =18.5 but = 32 kg/m2;
h)be willing to refrain from exercise, alcohol, hot spicy food, hot drinks and any medication, homeopathic, home remedy, dietary supplement, herbal remedy, and saline spray listed in the exclusion criteria throughout the study;
i)be willing and able to comply with MRI instructions (Appendix 3);
j)be willing to refrain from smoking, eating and drinking during Visit 1 and starting 1 hour prior to and during Visit 2 (room temperature water will be permitted ad lib while at the site); and,
k)have a peak nasal inspiratory flow of < 105 L/min (Section 3.4.2.2).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from the study if any of the following apply:

a)are female and have a positive urine pregnancy test at screening or report they are pregnant, trying to become pregnant, or lactating;
b)have a body temperature greater than 38.1º Celsius;
c)have blood pressure exceeding either 138mm Hg systolic or 88mm Hg diastolic (an average of three readings after sitting for 5 minutes);
d)have a history of rhinitis medicamentosa or frequent nose bleeds;
e)have a dependence upon nasal, oral, or ocular decongestants, that, in the opinion of the Investigator would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results;
f)have a clinically significant nasal abnormality (e.g., deviated septum, ulcer, septal perforation, or polyp) discovered during the nasal examination;
g)have a history of cardiovascular disease, thyroid disease, diabetes mellitus, hypertension, prostatic hypertrophy, hepatic or renal disease;
h)have a history of clinically significant pulmonary, autoimmune, psychiatric, metabolic, neurologic, hematologic/oncologic (except for treated basal cell carcinoma with a documented 6-month remission), metabolic, endocrine or gastrointestinal disease;
i)have an acute illness (other than cold and hay fever) during the two weeks preceding the study or have a condition or are taking a medication that the Investigator believes would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results;
j)have a history of allergy or hypersensitivity or abnormal reaction to Vicks® Sinex® Micromist® or the following ingredients: oxymetazoline hydrochloride, levomenthol, sodium citrate dihydrate, tyloxapol, citric acid anhydrous, chlorhexidine gluconate solution, benzalkonium chloride solution, camphor, disodium edetate dihydrate, eucalyptol, sodium hydroxide and purified water
k)have a history of alcohol or drug abuse within the past 2 years;
l)have used intranasal or systemic corticosteroids or leukotriene antagonists/synthase inhibitors within the past 30 days;
m)have used inhaled, topical, or oral nedocromil or intranasal cromolyn, tricyclic antidepressant medications, or MAO inhibitors within the past 14 days;
n)have used intranasal or systemic decongestants or intranasal or systemic antihistamines within the past 3 days;
o)are taking bromocriptine, antibiotics or antiviral medications;
p)have consumed alcohol, nasal, throat or lung inhalants, or any products (e.g., medications, homeopathics, home remedies, dietary supplements, herbal remedies, saline sprays) for common cold or hay fever within the past 12 hours;
q)have exercised within the past 6 hours;
r)are currently enrolled in another clinical trial, or have received any other investigational drug within the past 3 months;
s)do not meet all the criteria in the MR Safety Screening Questionnaire (Appendix 2)
t)are unable to follow MRI instructions (Appendix 3);
u)have demonstrated an unwillingness to comply with protocol requirements (e.g., uncooperative attitude, inability to return for all scans, history of medical non-compliance) and/or poor likelihood of completing the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified