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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00070707
Recruitment Status : Completed
First Posted : October 10, 2003
Results First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Asthma Drug: Mometasone Drug: Placebo Drug: Albuterol/Salbutamol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma
Actual Study Start Date : April 3, 2003
Actual Primary Completion Date : November 26, 2003
Actual Study Completion Date : November 26, 2003


Arm Intervention/treatment
Experimental: Mometasone
Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks
Drug: Mometasone
Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.
Other Name: Nasonex

Drug: Albuterol/Salbutamol
Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
Other Name: Proventil HFA

Placebo Comparator: Placebo
Matching placebo nasal spray, administered QD for 4 weeks
Drug: Placebo
Matching placebo nasal spray, administered QD as 2 sprays in each nostril.

Drug: Albuterol/Salbutamol
Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
Other Name: Proventil HFA




Primary Outcome Measures :
  1. Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) [ Time Frame: Baseline up to Week 4 ]
    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).


Secondary Outcome Measures :
  1. Change From Baseline in AM and PM Cough Symptom Score [ Time Frame: Baseline up to Week 4 ]
    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).

  2. Change From Baseline in AM and PM Wheeze Symptom Score [ Time Frame: Baseline up to Week 4 ]
    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).

  3. Change From Baseline in AM and PM Difficulty Breathing Symptom Score [ Time Frame: Baseline up to Week 4 ]
    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).

  4. Change From Baseline in AM and PM Chest Tightness Symptom Score [ Time Frame: Baseline up to Week 4 ]
    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).

  5. Change From Baseline in Pulmonary Auscultation/Wheezing Assessment [ Time Frame: Baseline, Day 15 and Day 29 ]
    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.

  6. Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) [ Time Frame: Baseline up to Week 4 ]
    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).

  7. Change From Baseline in AM and PM Rhinorrhea Symptom Score [ Time Frame: Baseline up to Week 4 ]
    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).

  8. Change From Baseline in AM and PM Nasal Itching Symptom Score [ Time Frame: Baseline up to Week 4 ]
    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).

  9. Change From Baseline in AM and PM Nasal Sneezing Symptom Score [ Time Frame: Baseline up to Week 4 ]
    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).

  10. Change From Baseline in AM and PM Nasal Congestion Symptom Score [ Time Frame: Baseline up to Week 4 ]
    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).

  11. Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) [ Time Frame: Baseline up to Week 4 ]
    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).

  12. Change From Baseline in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline, Day 15 and Day 29 ]
    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.

  13. Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline, Day 15 and Day 29 ]
    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.

  14. Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) [ Time Frame: Baseline, Day 15 and Day 29 ]
    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.

  15. Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used [ Time Frame: Baseline up to Week 4 ]
    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).

  16. Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma [ Time Frame: Baseline up to Week 4 ]
    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).

  17. Change From Baseline in Weekly Average Interference With Sleep [ Time Frame: Baseline up to Week 4 ]
    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).

  18. Change From Baseline in Weekly Average Interference With Daily Activities [ Time Frame: Baseline up to Week 4 ]
    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).

  19. Therapeutic Response to Asthma Symptoms [ Time Frame: Day 15 and Day 29 ]
    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).

  20. Therapeutic Response to SAR Nasal Symptoms [ Time Frame: Day 15 and Day 29 ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070707


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Integrated Therapeutics Group
Investigators
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Study Director: Medial Director Merck Sharp & Dohme Corp.
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00070707    
Other Study ID Numbers: P03280
MK-0887-064 ( Other Identifier: Merck )
First Posted: October 10, 2003    Key Record Dates
Results First Posted: July 18, 2019
Last Update Posted: July 18, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Seasonal Allergic Rhinitis
Asthma
Additional relevant MeSH terms:
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Asthma
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents