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

NCT00070707 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: P03280MK-0887-064
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rhinitis, Allergic, Seasonal; Asthma

Keywords

Seasonal Allergic Rhinitis; Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS)

  Each morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her asthma symptoms. The TASS was the sum of severity scores for 4 asthma symptoms: cough, wheeze, difficulty of breathing, and chest tightness. The severity of each asthma symptom was rated on a 4-point scale (0=no symptom; 3=severe); minimum TASS=0; maximum TASS=12. A decrease in TASS indicated an improvement in asthma symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).

  Baseline up to Week 4

Secondary Outcomes (20)

• Change From Baseline in AM and PM Cough Symptom Score

  Baseline up to Week 4

• Change From Baseline in AM and PM Wheeze Symptom Score

  Baseline up to Week 4

• Change From Baseline in AM and PM Difficulty Breathing Symptom Score

  Baseline up to Week 4

• Change From Baseline in AM and PM Chest Tightness Symptom Score

  Baseline up to Week 4

• Change From Baseline in Pulmonary Auscultation/Wheezing Assessment

  Baseline, Day 15 and Day 29

Study Arms (2)

Mometasone

EXPERIMENTAL

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

Drug: Mometasone; Drug: Albuterol/Salbutamol

Placebo

PLACEBO COMPARATOR

Matching placebo nasal spray, administered QD for 4 weeks

Drug: Placebo; Drug: Albuterol/Salbutamol

Interventions

Mometasone DRUG

Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.

Also known as: Nasonex

Mometasone

Placebo DRUG

Matching placebo nasal spray, administered QD as 2 sprays in each nostril.

Placebo

Albuterol/Salbutamol DRUG

Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.

Also known as: Proventil HFA

Mometasone; Placebo

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Organon and Co: lead
• Integrated Therapeutics Group: collaborator

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Asthma

Interventions

Mometasone Furoate; Albuterol

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medial Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2003
• First Posted: October 10, 2003
• Study Start: April 3, 2003
• Primary Completion: November 26, 2003
• Study Completion: November 26, 2003
• Last Updated: September 5, 2024
• Results First Posted: July 18, 2019

Record last verified: 2022-02