Assess Efficacy and Safety of a Nasal Spray in Adults With Dry or Irritated Nose (NCT06110117) | Clinical Trial Compass
CompletedNot Applicable
Assess Efficacy and Safety of a Nasal Spray in Adults With Dry or Irritated Nose
Poland70 participantsStarted 2023-10-27
Plain-language summary
The goal of this clinical trial is to test symptom relief in subjects suffering from irritated or dry nasal passages. The main question it aims to answer is whether use of the nasal spray provides relief from dry nose symptoms. Participants will use the product for one week and report on the severity of their symptoms before and during use.
Who can participate
Age range18 Years ā 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Male and female subjects ā„18 years of age;
ā. Subjects must have ongoing nasal irritation or dryness at Visit 1 (Day -4);
ā. Total Irritation Score (sum of all 12 symptom scores) must average at least 8 over the three-day run-in period (Day -3 to -1) and must be at least 8 at Visit 2 (Day 0). (Individual symptom score range is 0 - 3; Total Irritation Score range is 0 - 36.)
ā. Dry Nose Symptom Score must average at least 2 over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Dry nose symptom score range is 0 - 3.)
ā. The score of at least two other symptoms beside dry nose must average at least 2 over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Each symptom score range is 0 - 3.)
ā. Twenty-five percent of the included subjects must have ongoing nasal symptoms caused by indoor pollutants from fireplaces, candles, smoking, or cooking, verified by principal investigator;
ā. Subjects are willing to refrain from using any medications and/or acts for relief of nasal symptoms during the whole study from Day -4 to Day 7; except for acetaminophen, ibuprofen, or vitamins;
ā. Subjects are willing and able to comply with the requirements of the study to use the study product according to use instructions, complete the daily symptom and product diaries and questionnaire(s), and visit the test facility as instructed;
Exclusion criteria
ā. Currently taking any over-the-counter and prescription systemic/topical corticosteroids, antibiotics, antihistamines, cromone, nonsteroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists or topical or systemic decongestants within the two weeks prior to Visit 1;
What they're measuring
1
Change in patient-reported total irritation score from baseline
ā. Currently using other nasal sprays, nasal pumps, nasal irrigation/lavage devices, or oils, creams, or gels into the nose;
ā. Women who are pregnant and/or breastfeeding or planning to become pregnant during the study and within 30 days after the last application of the study product;
ā. Have a dermatologic, respiratory, or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.) which, in the opinion of the principal investigator, could interfere with the interpretation of study results at the time of the screening visit (Day -4);
ā. Have a positive medical history of any significant illness within the 2 weeks prior to the screening visit (Day -4), which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
ā. Have a known allergy to any food or personal care products;
ā. Have any kind of immunodeficiency;
ā. Have a history of sensitivity to products as related to the product being evaluated;