A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution

McNeil-PPC

Status and phase: Completed; Phase 4

Conditions: Rhinitis

Treatments: Other: Placebo; Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04132570

5034003ALY4002 (Other Identifier)

CCSURA001265 (Other Identifier)

Details and patient eligibility

About

The primary objective of this study is to assess the effectiveness of intranasal budesonide aqueous spray 256 microgram (mcg)/day for treatment of rhinitis symptoms during times of high airborne pollution.

Enrollment: 206 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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206 participants in 2 patient groups, including a placebo group

Budesonide 256 mcg per Day (Treatment A)

Experimental group

Description:

Participants will self-administer 2 nasal sprays of Budesonide (64 microgram \[mcg\]/spray) in each nostril once daily (every morning) up to 10 +\\- 3 Days.

Treatment:

Drug: Budesonide

Placebo (Treatment B)

Placebo Comparator group

Description:

Participants will self-administer 2 nasal sprays of matching placebo in each nostril once daily (in the morning) up to 10 +\\- 3 Days.

Treatment:

Other: Placebo