Rhinitis, Allergic, SeasonalPhase 4NCT00070707
Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)
A Phase 4 study testing Mometasone and Albuterol/Salbutamol in people with Rhinitis, Allergic, Seasonal and Asthma, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Asthma
- What is being tested?
- Mometasone and Albuterol/Salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 3 Apr 2003to 26 Nov 2003
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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
About this study
Official title: Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma
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
- Being tested
- Mometasone, Placebo, Albuterol/Salbutamol
- Keywords
- Seasonal Allergic Rhinitis, Asthma
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MometasoneDrug
Also called Nasonex
Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.
PlaceboDrug
Matching placebo nasal spray, administered QD as 2 sprays in each nostril.
Albuterol/SalbutamolDrug
Also called Proventil HFA
Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
| Study group | Role | What they receive |
|---|---|---|
| Mometasone | Experimental | Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks Receives: Drug: Mometasone; Drug: Albuterol/Salbutamol |
| Placebo | Placebo comparator | Matching placebo nasal spray, administered QD for 4 weeks Receives: Drug: Placebo; Drug: Albuterol/Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline up to Week 4
Secondary outcomes (20)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 15 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2003 (estimated)
- Study start3 Apr 2003
- Primary completion26 Nov 2003
- Study completion26 Nov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrated Therapeutics Group
- Responsible party
- Sponsor
- Investigators
- Medial Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070707
- Sponsor's protocol ID
- P03280
- Other IDs
- MK-0887-064
- Status last verified
- Feb 2022
- First submitted
- 7 Oct 2003
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma
- ClinicalTrials.gov ID
- NCT00070707
- Acronym / sponsor ID
- P03280
- Conditions
- Rhinitis, Allergic, Seasonal, Asthma
- Keywords
- Seasonal Allergic Rhinitis, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Integrated Therapeutics Group
- Study start
- 3 Apr 2003 (actual)
- Primary completion
- 26 Nov 2003 (actual)
- Study completion
- 26 Nov 2003 (actual)
- First posted
- 10 Oct 2003 (estimated)
- Results
- Posted 18 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone | Experimental | Drug: Mometasone, Drug: Albuterol/SalbutamolMometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Albuterol/SalbutamolMatching placebo nasal spray, administered QD for 4 weeks |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MometasoneAlso: NasonexMometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril. | Drug | Mometasone |
| PlaceboMatching placebo nasal spray, administered QD as 2 sprays in each nostril. | Drug | Placebo |
| Albuterol/SalbutamolAlso: Proventil HFAAlbuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication. | Drug | Mometasone, Placebo |
Primary outcome
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).
20 secondary outcomes
Change From Baseline in AM and PM Cough Symptom Score
Time frame: Baseline up to Week 4
Change From Baseline in AM and PM Wheeze Symptom Score
Time frame: Baseline up to Week 4
Change From Baseline in AM and PM Difficulty Breathing Symptom Score
Time frame: Baseline up to Week 4
Change From Baseline in AM and PM Chest Tightness Symptom Score
Time frame: Baseline up to Week 4
Change From Baseline in Pulmonary Auscultation/Wheezing Assessment
Time frame: Baseline, Day 15 and Day 29
Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS)
Time frame: Baseline up to Week 4
Change From Baseline in AM and PM Rhinorrhea Symptom Score
Time frame: Baseline up to Week 4
Change From Baseline in AM and PM Nasal Itching Symptom Score
Time frame: Baseline up to Week 4
Change From Baseline in AM and PM Nasal Sneezing Symptom Score
Time frame: Baseline up to Week 4
Change From Baseline in AM and PM Nasal Congestion Symptom Score
Time frame: Baseline up to Week 4
Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline up to Week 4
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline, Day 15 and Day 29
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline, Day 15 and Day 29
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
Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used
Time frame: Baseline up to Week 4
Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma
Time frame: Baseline up to Week 4
Change From Baseline in Weekly Average Interference With Sleep
Time frame: Baseline up to Week 4
Change From Baseline in Weekly Average Interference With Daily Activities
Time frame: Baseline up to Week 4
Therapeutic Response to Asthma Symptoms
Time frame: Day 15 and Day 29
Therapeutic Response to SAR Nasal Symptoms
Time frame: Day 15 and Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medial Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone and Albuterol/Salbutamol in people with Rhinitis, Allergic, Seasonal and Asthma, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) (time frame: Baseline up to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.