Clinical trial NCT00070707: Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)
Official title: Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Seasonal
Asthma
Keywords: Seasonal Allergic Rhinitis
Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Integrated Therapeutics Group
First posted: 2003-10-10
Enrollment: 188
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS)
timeFrame: Baseline up to Week 4
Secondary outcomes:
measure: Change From Baseline in AM and PM Cough Symptom Score
timeFrame: Baseline up to Week 4
measure: Change From Baseline in AM and PM Wheeze Symptom Score
timeFrame: Baseline up to Week 4
measure: Change From Baseline in AM and PM Difficulty Breathing Symptom Score
timeFrame: Baseline up to Week 4
measure: Change From Baseline in AM and PM Chest Tightness Symptom Score
timeFrame: Baseline up to Week 4
measure: Change From Baseline in Pulmonary Auscultation/Wheezing Assessment
timeFrame: Baseline, Day 15 and Day 29
measure: Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS)
timeFrame: Baseline up to Week 4
measure: Change From Baseline in AM and PM Rhinorrhea Symptom Score
timeFrame: Baseline up to Week 4
measure: Change From Baseline in AM and PM Nasal Itching Symptom Score
timeFrame: Baseline up to Week 4
measure: Change From Baseline in AM and PM Nasal Sneezing Symptom Score
timeFrame: Baseline up to Week 4
measure: Change From Baseline in AM and PM Nasal Congestion Symptom Score
timeFrame: Baseline up to Week 4
measure: Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR)
timeFrame: Baseline up to Week 4
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline, Day 15 and Day 29
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline, Day 15 and Day 29
measure: Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%)
timeFrame: Baseline, Day 15 and Day 29
measure: Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used
timeFrame: Baseline up to Week 4
measure: Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma
timeFrame: Baseline up to Week 4
measure: Change From Baseline in Weekly Average Interference With Sleep
timeFrame: Baseline up to Week 4
measure: Change From Baseline in Weekly Average Interference With Daily Activities
timeFrame: Baseline up to Week 4
measure: Therapeutic Response to Asthma Symptoms
timeFrame: Day 15 and Day 29
measure: Therapeutic Response to SAR Nasal Symptoms
timeFrame: Day 15 and Day 29
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medial Director
role: STUDY_DIRECTOR
References: