Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Self-reported rhinitis symptoms triggered or worsened by airborne pollution, with agreement by physician at screening visit
Participant must have moderate to severe rhinitis symptoms as defined by a 24-hour reflective total nasal symptom score (rTNSS) of at least 5 (maximum 9), based on three individual nasal symptom scores (nasal obstruction, secretion/runny nose, itching/sneezing) at the time of the screening visit, including at least one individual symptom score of 3 for nasal obstruction and/or secretion/runny nose
Regularly have outdoor exposure during a normal week in the winter season, including greater than or equal to (>=) 1 hour on most days. Outdoor exposure may include commuting activities (such as walking/bicycle/auto/bus/city metro train travel), outdoor work, exercise, shopping, or other outdoor activities
A woman of childbearing potential must have a negative urine pregnancy test (beta human chorionic gonadotropin [beta hCG]) at screening and agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after the last administration of study agent
Male participants who are not surgically sterilized and are heterosexually active with a woman of childbearing potential, must agree to use a barrier method of contraception (example condom with spermicidal foam/gel/film/cream/suppository) and to not donate sperm during the study and for 30 days after last receiving study agent. Note that barrier methods must also be used in all male subjects sexually active with pregnant partners for at least 30 days after last study agent administration
Participants can understand the questionnaires and are able to complete the questionnaires in the format provided
Reside in the same city as the study site that they will be visiting

Exclusion Criteria:

History of hypersensitivity to budesonide or any ingredients in the formulation
Upper respiratory infection within 2 weeks of screening visit
Current symptoms consistent with diagnosis of common cold, influenza, or other respiratory infection according to physician evaluation
Using of N-95 masks days during with high airborne pollution
Presence of nasal polyps or deviated septum as confirmed by nasal endoscopy
History of nasal surgery
Presence of chronic or active rhinosinusitis or sinusitis
Systemic, intranasal or topical corticosteroid use within 1 month, intranasal or systemic decongestants within 3 days, antihistamine use within 1 week, intranasal cromolyn within 2 weeks, leukotriene use within 1 month, or immunotherapy within 2 years of screening visit
Asthma, with the exception of mild intermittent asthma not requiring medication
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (example compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments