Allergic RhinitisPhase 3NCT00599027
An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma
A Phase 3 study testing Mometasone furoate nasal spray (MFNS) in people with Allergic Rhinitis and Asthma, run by Organon and Co.
Trial summary
The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Rhinitis, Asthma
- What is being tested?
- Mometasone furoate nasal spray (MFNS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- May 2008to May 2009
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients (≥18 and ≤ 75 years of age) of either sex
- Willingness to participate and comply with procedures by signing a written informed consent
- Moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks)
- To qualify at the randomization visit the daily average of the T5SS [(Morning-time T5SS + Evening-time T5SS)/2] had to be ≥ 6 in at least 4 days during the 1 week run-in period
- Positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial were required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level >3.5 U/mL)
- All prior medication washout times had been observed
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- Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication
- Negative urine pregnancy test
- Free of any clinically relevant disease that would have interfered with study evaluations
- Able to adhere to the dosing and visit schedules, and agree to record symptom severity scores and use of IMP and rescue medications in a daily diary
Who cannot join
- Female who was or intended to become pregnant during the study or within 12 weeks after study completion
- Nursing, or intended to be nursing during the study or within 12 months after study completion
- Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
- Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
- Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
- Rhinitis medicamentosa
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- Evidence of persistent asthma, or asthma with daytime and nighttime symptoms not controlled by short-acting beta2-adrenoceptor agonists
- Asthma requiring chronic use of inhaled or systemic corticosteroids
- Upper respiratory tract or sinus infection that required antibiotic therapy and had not had at least a 14-day wash-out period prior to the run-in period, or had a viral upper respiratory infection within 7 days prior to screening
- Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
- Undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the screening visit were eligible for study inclusion; however, subject could not receive hyposensitization treatment within 24 hours prior to any study visit
- Diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas)
- Concomitant medical problem
- Had any of the following clinical conditions: active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex
- Smoked or had smoked within the previous 6 months
- Member of the staff, affiliated with, or family member of the staff personnel directly involved with this study
- Previously randomized into this study
- Any other clinically significant deviation from normal in the physical examination or medical history that could interfere with the study evaluation or affect subject safety
- In a situation or condition that could interfere with participation in the study
- Used any drug or device in an investigational protocol in the 30 days prior to visit 1
- Participating in other clinical studies
- Allergic or has sensitivity to the study drug or its excipients
- Compromised ability to provide informed consent
- History of non-compliance with medication or treatment protocols
About this study
Official title: An Exploratory Study of Mometasone Furoate Nasal Spray in Patients With Moderate-severe Persistent Allergic Rhinitis and Intermittent Asthma: Effects on the Quality of Life Evaluated With the Rhinasthma Questionnaire
The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of allergic rhinitis and asthma.
Read the detailed description
The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). In addition, there are two secondary objectives. The first secondary objective is to evaluate the efficacy of MFNS in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Upper Airways Score, the Rhinasthma Lower Airways Score, and the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to evaluate the efficacy of MFNS in relieving the subject's symptoms of allergic rhinitis and asthma as measured by the Total 5 Symptoms Score (T5SS) and the Global Symptom Score (T5SS+asthma symptoms) and by the use of rescue medication on demand.
- Conditions
- Allergic Rhinitis, Asthma
- Being tested
- Mometasone furoate nasal spray (MFNS), Placebo nasal spray
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoate nasal spray (MFNS)Drug
Also called Nasonex Nasal Spray
Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
Placebo nasal sprayDrug
Also called Placebo
Placebo nasal spray once daily (two puffs per nostril) in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Mometasone furoate nasal spray | Experimental | Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. Receives: Drug: Mometasone furoate nasal spray (MFNS) |
| Placebo nasal spray | Placebo comparator | Placebo nasal spray once daily (two puffs per nostril) in the morning. Receives: Drug: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.
To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30.
Measured: Baseline and 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599027
- Sponsor's protocol ID
- P05277
- Status last verified
- Feb 2022
- First submitted
- 10 Jan 2008
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Baiardini I, Villa E, Rogkakou A, Pellegrini S, Bacic M, Compalati E, Braido F, Le Grazie C, Canonica GW, Passalacqua G. Effects of mometasone furoate on the quality of life: a randomized placebo-controlled trial in persistent allergic rhinitis and intermittent asthma using the Rhinasthma questionnaire. Clin Exp Allergy. 2011 Mar;41(3):417-23. doi: 10.1111/j.1365-2222.2010.03660.x. Epub 2010 Dec 1.
PubMed 21121983
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Mometasone Furoate Nasal Spray in Patients With Moderate-severe Persistent Allergic Rhinitis and Intermittent Asthma: Effects on the Quality of Life Evaluated With the Rhinasthma Questionnaire
- ClinicalTrials.gov ID
- NCT00599027
- Acronym / sponsor ID
- P05277
- Conditions
- Allergic Rhinitis, Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Jan 2008 (estimated)
- Results
- Posted 30 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of allergic rhinitis and asthma.
Detailed description
The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). In addition, there are two secondary objectives. The first secondary objective is to evaluate the efficacy of MFNS in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Upper Airways Score, the Rhinasthma Lower Airways Score, and the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to evaluate the efficacy of MFNS in relieving the subject's symptoms of allergic rhinitis and asthma as measured by the Total 5 Symptoms Score (T5SS) and the Global Symptom Score (T5SS+asthma symptoms) and by the use of rescue medication on demand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone furoate nasal spray | Experimental | Drug: Mometasone furoate nasal spray (MFNS)Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. |
| Placebo nasal spray | Placebo comparator | Drug: Placebo nasal sprayPlacebo nasal spray once daily (two puffs per nostril) in the morning. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Outpatients (≥18 and ≤ 75 years of age) of either sex
- Willingness to participate and comply with procedures by signing a written informed consent
- Moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks)
- To qualify at the randomization visit the daily average of the T5SS [(Morning-time T5SS + Evening-time T5SS)/2] had to be ≥ 6 in at least 4 days during the 1 week run-in period
- Positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial were required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level >3.5 U/mL)
Key exclusion criteria (24 listed)
- Female who was or intended to become pregnant during the study or within 12 weeks after study completion
- Nursing, or intended to be nursing during the study or within 12 months after study completion
- Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
- Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
- Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
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 |
|---|---|---|
| Mometasone furoate nasal spray (MFNS)Also: Nasonex Nasal SprayMometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. | Drug | Mometasone furoate nasal spray |
| Placebo nasal sprayAlso: PlaceboPlacebo nasal spray once daily (two puffs per nostril) in the morning. | Drug | Placebo nasal spray |
Primary outcome
The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.
Time frame: Baseline and 28 days of treatment
To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21121983Baiardini I, Villa E, Rogkakou A, Pellegrini S, Bacic M, Compalati E, Braido F, Le Grazie C, Canonica GW, Passalacqua G. Effects of mometasone furoate on the quality of life: a randomized placebo-controlled trial in persistent allergic rhinitis and intermittent asthma using the Rhinasthma questionnaire. Clin Exp Allergy. 2011 Mar;41(3):417-23. doi: 10.1111/j.1365-2222.2010.03660.x. Epub 2010 Dec 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone furoate nasal spray (MFNS) in people with Allergic Rhinitis 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 10 inclusion and 24 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 21 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 30 Apr 2010). 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?
The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment. (time frame: Baseline and 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00599027, which also lists 1 linked publication.
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 21 May 2024.