Phase 4
N=188
Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)
Rhinitis, Allergic, Seasonal · Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00070707 ↗Enrolled (actual)
188
Serious AEs
1.1%
Results posted
Jul 2019
Primary outcome: Primary: Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) — 6.5; 5.9; -0.9; -1.4 Score on a scale — p=0.101
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mometasone (Drug); Placebo (Drug); Albuterol/Salbutamol (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Nov 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) |
6.5; 5.9; -0.9; -1.4; -1.5; -1.5 | 0.101 |
| SECONDARY Change From Baseline in AM and PM Cough Symptom Score |
1.7; 1.5; -0.3; -0.3; -0.4; -0.4 | 0.023 sig |
| SECONDARY Change From Baseline in AM and PM Wheeze Symptom Score |
1.5; 1.3; -0.2; -0.3; -0.4; -0.3 | 0.068 |
| SECONDARY Change From Baseline in AM and PM Difficulty Breathing Symptom Score |
1.7; 1.6; -0.3; -0.3; -0.4; -0.4 | 0.078 |
| SECONDARY Change From Baseline in AM and PM Chest Tightness Symptom Score |
1.6; 1.6; -0.2; -0.4; -0.3; -0.4 | 0.629 |
| SECONDARY Change From Baseline in Pulmonary Auscultation/Wheezing Assessment |
11; 9; 101; 66; 8; 4 | 0.532 |
| SECONDARY Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) |
8.4; 7.9; -1.7; -0.9; -2.3; -1.3 | 0.104 |
| SECONDARY Change From Baseline in AM and PM Rhinorrhea Symptom Score |
2.2; 2.1; -0.3; -0.2; -0.5; -0.3 | 0.136 |
| SECONDARY Change From Baseline in AM and PM Nasal Itching Symptom Score |
2.0; 1.9; -0.4; -0.2; -0.6; -0.3 | 0.181 |
| SECONDARY Change From Baseline in AM and PM Nasal Sneezing Symptom Score |
1.8; 1.7; -0.5; -0.2; -0.6; -0.6 | 0.089 |
| SECONDARY Change From Baseline in AM and PM Nasal Congestion Symptom Score |
2.3; 2.3; -0.4; -0.3; -0.5; -0.4 | 0.745 |
| SECONDARY Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) |
382.5; 362.3; 0.9; 1.0; 4.3; 4.1 | 0.116 |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) |
2.98; 3.00; 0.05; 0.07; 0.04; 0.02 | 0.823 |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) |
3.75; 3.80; 0.02; 0.00; -0.00; 0.00 | 0.693 |
| SECONDARY Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) |
2.98; 3.00; 0.12; 0.00; 0.15; 0.03 | 0.823 |
| SECONDARY Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used |
2.4; 2.1; -0.4; -0.5; -0.6; -0.5 | 0.375 |
| SECONDARY Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma |
0.6; 0.6; -0.1; -0.2; -0.1; -0.2 | 0.865 |
| SECONDARY Change From Baseline in Weekly Average Interference With Sleep |
1.3; 1.2; -0.2; -0.2; -0.4; -0.3 | 0.667 |
| SECONDARY Change From Baseline in Weekly Average Interference With Daily Activities |
1.5; 1.4; -0.3; -0.4; -0.4; -0.3 | 0.363 |
| SECONDARY Therapeutic Response to Asthma Symptoms |
3.4; 3.4; 3.2; 3.5 | 0.954 |
| SECONDARY Therapeutic Response to SAR Nasal Symptoms |
3.2; 3.4; 3.0; 3.4 | 0.268 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00070707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.