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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma

Conditions
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Rhinitis, Allergic, Seasonal, Asthma

Intervention / Treatment
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* Drug: Mometasone
* Drug: Placebo
* Drug: Albuterol/Salbutamol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone<br>Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks | Drug: Mometasone<br>* Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.<br>* Other names: Nasonex;Drug: Albuterol/Salbutamol<br>* Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.<br>* Other names: Proventil HFA;|
| Placebo Comparator: Placebo<br>Matching placebo nasal spray, administered QD for 4 weeks | Drug: Placebo<br>* Matching placebo nasal spray, administered QD as 2 sprays in each nostril.<br>Drug: Albuterol/Salbutamol<br>* Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.<br>* Other names: Proventil HFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in AM and PM Cough Symptom Score | Cough is an asthma symptom assessed by participants who used diary cards to record morning and evening cough (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her coughing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Cough was rated on a 4-point scale (0=no symptoms [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). Reduction in score indicated an improvement in cough 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 | 
| Change From Baseline in AM and PM Wheeze Symptom Score | Wheezing is a symptom of asthma. The wheezing assessment was based on participant diary data only. Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her wheezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Wheeze severity was rated on a 4-point scale (0=no wheezing [best score] to 3=wheezing was hard to tolerate and interfered with daily life activity [worst score]). 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 | 
| Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Difficulty breathing is an asthma symptom assessed by participants using diary cards to record morning and evening difficulty breathing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her difficulty breathing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Difficulty breathing was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). 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 | 
| Change From Baseline in AM and PM Chest Tightness Symptom Score | Chest tightness is an asthma symptom assessed by participants using diary cards to record morning and evening chest tightness (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her chest tightness for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). The severity of chest tightness was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). 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 | 
| Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Wheezing was assessed by the investigator or designee based upon pulmonary auscultation (listening with a stethoscope) and reported in the case report form as present or absent. The count of wheezing presence (yes, no) at visits was summarized. | Baseline, Day 15 and Day 29 | 
| Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | The Total Nasal Symptom Severity (TNSS) is the sum of severity scores for 4 nasal symptoms: nasal rhinorrhea, nasal stuffiness/congestion, sneezing, and nasal itching as assessed in the participant diaries. The severity of each nasal symptom was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]); minimum TNSS=0; maximum TNSS=12. A decrease in TNSS indicated an improvement in nasal 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 | 
| Change From Baseline in AM and PM Rhinorrhea Symptom Score | Rhinorrhea is a symptom of seasonal allergic rhinitis (SAR) assessed by participants using diary cards to record morning and evening rhinorrhea (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her rhinorrhea for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Rhinorrhea was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). 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 | 
| Change From Baseline in AM and PM Nasal Itching Symptom Score | Nasal itching is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal itching (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal itching for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). 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 | 
| Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Nasal sneezing is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal sneezing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal sneezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms a were hard to tolerate and interfered with daily life activity [worst score]). 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 | 
| Change From Baseline in AM and PM Nasal Congestion Symptom Score | Nasal congestion is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal congestion (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal congestion for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). 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 | 
| Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Participants used a peak flow meter to measure the rate of air forcibly expelled from the lungs. They performed triplicate PEFR measurements in the morning prior to taking their study medication and again in the evening, and documented the highest of the three values in their diaries. A day with worsening asthma was any day during which a decrease from baseline in morning (AM) PEFR of more than 25% occurred. 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 | 
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Measured by the investigator (or a designated assistant) using a spirometer, FEV1 is the volume of air forcibly expelled from the lungs in one second. | Baseline, Day 15 and Day 29 | 
| Change From Baseline in Forced Vital Capacity (FVC) | Measured by the investigator (or a designated assistant) using a spirometer, FVC is the total volume of air forcibly expelled from the lungs after taking the deepest breath possible. | Baseline, Day 15 and Day 29 | 
| Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Measured by the investigator (or a designated assistant) using a spirometer, FEF25%-75% is the average forcibly expelled air flow rate, measured between 75% and 25% of FVC. | Baseline, Day 15 and Day 29 | 
| Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Once daily, participants recorded in their diaries the total number of puffs of albuterol/salbutamol used in each 24-hour period. 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 | 
| Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Participants recorded the number of times during the night they awakened due to asthma. 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 | 
| Change From Baseline in Weekly Average Interference With Sleep | Interference with sleep was rated once each morning using a 4-point scale ranging from 0 (none) to 3 (substantially interferes with sleep). 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 | 
| Change From Baseline in Weekly Average Interference With Daily Activities | Interference with daily activities was rated once each evening using a 4-point scale ranging from 0 (none) to 3 (substantially interfered with activities or not able to perform the activities at all). 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 | 
| Therapeutic Response to Asthma Symptoms | On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of asthma symptoms with those noted on Day 1. Therapeutic response for asthma symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief). | Day 15 and Day 29 | 
| Therapeutic Response to SAR Nasal Symptoms | On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of SAR symptoms with those noted on Day 1. Therapeutic response for SAR symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief). | Day 15 and Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal Allergic Rhinitis, Asthma