Acute RhinosinusitisNCT05639959
Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial
An observational study of Acute Rhinosinusitis, run by Saffron Pharma at 1 site in Pakistan.
Trial summary
Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Acute Rhinosinusitis
- What is being tested?
- Mometasone Nasal 50 Mcg/Inh Nasal Spray and Nasal spray
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2022to 6 Nov 2022
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 50 years
- All sexes
- Child, Adult
Study population: Ages Eligible for Study: 10 Years to 50 Years older Sexes Eligible for Study: All Accepts Healthy Volunteers: No Children and adults of any age who had a diagnosis of rhinitis sicca, symptoms of dry nose brought on by the use of specific drugs, or who were receiving concurrent treatment for allergies or rhinosinusitis were eligible for the study
Who may be able to join
- Children and adults of age (10-50) who had a diagnosis of rhinitis
- Ability and willingness to understand and provide informed consent.
Who cannot join
- Known current pregnancy.
- Current hospitalization.
- Unable to complete online questionnaires or adhere to study requirements.
- Kidney failure or dialysis; severe liver disease or cirrhosis.
- Any parathyroid conditions.
- Known current pregnancy.
- History of SARS-CoV-2 infection.
Trial locations and contacts
1 site in 1 country.
About this study
Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.
Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.
Read the detailed description
Background Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.
Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.
- Conditions
- Acute Rhinosinusitis
- Being tested
- Mometasone Nasal 50 Mcg/Inh Nasal Spray, Nasal spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Nasal 50 Mcg/Inh Nasal SprayDrug
Also called Hivate
Mometasone furoate nasal spray effectively reduced total and individual symptoms scores in patients with allergic rhinitis.
Nasal sprayDevice
device can work properly for actuation during trials
| Study group | Role | What they receive |
|---|---|---|
| Commercial product group | group who are taking commercial nasal spray products Receives: Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray; Device: Nasal spray | |
| New formulation product group | who are taking new formulation nasal spray product with same strength Receives: Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray; Device: Nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
congestion
The primary end outcomes were change from baseline in the subject's congestion and/or blockage score averaged throughout the first month of treatment and change from baseline in the physician's assessment of Allergic rhinitis.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start10 Sep 2022
- Primary completion6 Nov 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute RhinosinusitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Saffron Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Yasir Mehmood Mehmood, Saffron Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639959
- Sponsor's protocol ID
- QA/CT/001
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05639959
- Acronym / sponsor ID
- QA/CT/001
- Conditions
- Acute Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Saffron PharmaIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.
Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.
Detailed description
Background Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.
Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial product group | – | Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray, Device: Nasal spraygroup who are taking commercial nasal spray products |
| New formulation product group | – | Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray, Device: Nasal spraywho are taking new formulation nasal spray product with same strength |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Ages Eligible for Study: 10 Years to 50 Years older Sexes Eligible for Study: All Accepts Healthy Volunteers: No Children and adults of any age who had a diagnosis of rhinitis sicca, symptoms of dry nose brought on by the use of specific drugs, or who were receiving concurrent treatment for allergies or rhinosinusitis were eligible for the study
Key inclusion criteria (2 listed)
- Children and adults of age (10-50) who had a diagnosis of rhinitis
- Ability and willingness to understand and provide informed consent.
Key exclusion criteria (7 listed)
- Known current pregnancy.
- Current hospitalization.
- Unable to complete online questionnaires or adhere to study requirements.
- Kidney failure or dialysis; severe liver disease or cirrhosis.
- Any parathyroid conditions.
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 Nasal 50 Mcg/Inh Nasal SprayAlso: HivateMometasone furoate nasal spray effectively reduced total and individual symptoms scores in patients with allergic rhinitis. | Drug | Commercial product group, New formulation product group |
| Nasal spraydevice can work properly for actuation during trials | Device | Commercial product group, New formulation product group |
Primary outcome
congestion
Time frame: 3 weeks
The primary end outcomes were change from baseline in the subject's congestion and/or blockage score averaged throughout the first month of treatment and change from baseline in the physician's assessment of Allergic rhinitis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Rhinosinusitis, run by Saffron Pharma at 1 site in Pakistan.
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 2 inclusion and 7 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
congestion (time frame: 3 weeks). 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 7 Dec 2022.