Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma; Rhinitis, Allergic, Seasonal

Treatments: Drug: Albuterol/Salbutamol; Drug: Placebo; Drug: Mometasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00070707

MK-0887-064 (Other Identifier)

P03280

Details and patient eligibility

About

This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.

Enrollment: 188 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have at least a two-year history of seasonal allergic rhinitis and an increase in asthma symptoms associated with the allergy season under study
• Demonstrate an increase in absolute FEV 1 less than 12%, with an absolute volume increase of at least 200 ml, after reversibility testing within the past 12 months
• Is skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at screening, or within 12 months prior to the screening visit, to a seasonal allergen (which may include seasonal molds) prevalent during the study period.
• Female participants of childbearing potential use a medically accepted method of birth control and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Females who are not sexually active at time of study agree and consent to use a medically acceptable method of birth control should they become sexually active while participating in the study.

Exclusion criteria

• Female participants who are pregnant, intend to become pregnant during the duration of the study, or are nursing.
• Have asthma symptoms and require chronic use of inhaled or systemic corticosteroids.
• Have current or historical frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip.
• Have recent nasal septum ulcers, nasal surgery or nasal trauma, which should not be included until healing occurs.
• Have rhinitis medicamentosa or chronic obstructive pulmonary disease (COPD).
• Have an upper or lower respiratory tract or sinus infection that requires antibiotic therapy, or have a viral upper or lower respiratory infection.
• Have nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interferes with nasal air flow.
• Are dependent on nasal topical antihistamines, or nasal steroids.
• On immunotherapy (desensitization therapy) and will receive an increase in dose during the study; participants who will receive desensitization treatment within 24 hours prior to a study visit.
• Is a participant who smokes, or is an ex-smoker who has smoked within the previous six months.
• Is an investigator, study staff member, or family member involved with this study.
• Has active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, or systemic viral infections, or herpes simplex.
• Is a participant whose ability to provide informed consent is compromised.
• Has a history of non-compliance with medications or treatment protocols.
• Is morbidly obese (BMI >35).
• Is a night-shift worker or does not have a standard asleep at night/awake during the day cycle.
• Has any history of life-threatening asthma attacks or is treated in the emergency room or admitted to the hospital for asthma control within the previous 3 months or more than once in the previous 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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188 participants in 2 patient groups, including a placebo group

Mometasone

Experimental group

Description:

Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks

Treatment:

Drug: Mometasone

Drug: Albuterol/Salbutamol

Placebo

Placebo Comparator group

Description:

Matching placebo nasal spray, administered QD for 4 weeks

Treatment:

Drug: Placebo

Drug: Albuterol/Salbutamol