Rhinitis MedicamentosaPROUDNCT06817967
A Study Comparing Proponent Solution - Nasal Spray (PSNS) With Salt Water for Treating Nasal Congestion Symptoms in Adults With Rebound Nasal Congestion While Weaning From Nasal Decongestant Sprays
A study testing PSNS and ISNS in people with Rhinitis Medicamentosa, run by Pharma Nordic AS at 7 sites in Norway.
Trial summary
The purpose of the study was to test if the PROPONENT® nasal spray works, if it is safe, and if it helps participants to stop using addictive nasal decongestant sprays. To be able to take part in the study, participants had to be at least 18 years old, suffer from a condition called "rebound nasal congestion" or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis Medicamentosa
- What is being tested?
- PSNS and ISNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 7 sitesNorway
- Study dates
- 25 Feb 2024to 24 Jul 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed informed consent prior to any study-specific procedures.
- Be 18 years of age or older.
- Use xylometazoline or oxymetazoline nasal spray at least once daily over a period of 7 days, registered before entering the clinical study.
- Be diagnosed with RM by a medical doctor. The subject needed/wanted to wean from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline.
Who cannot join
- Had influenza, acute or chronic rhinitis (other than RM), acute sinusitis, suppurative tonsillitis, pneumonia, or tuberculosis.
- Had taken any medication or cold remedies to treat common colds (including Proponent Solution - Nasal Spray [PSNS]) within the last week.
- Had used glucocorticoids (tablets, injections, and topical inhalers) within the last week or will need this medication during the study.
- Had serious primary cardiovascular, kidney, liver, neurological, psychiatric, or haematological disease.
- Had a diagnosis of asthma, chronic obstructive pulmonary disease, chronic cough, or other significant acute or chronic respiratory conditions or disorders.
- Had an allergic disease and require daily peroral antihistamines for the treatment of the disease during the inclusion period and the study.
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- Study subject was a current smoker.
- Nasal disorder or nasal condition as a relevant septal deviation, polyposis, chronic rhinitis, ulcer, etc., and/or reconstructive surgery, that could impair nasal breathing.
- Had a known ongoing cancer disease.
- Was identified by the Investigator as inappropriate to participate in this study (e.g., inability to report daily using smartphone/computer [eDiary]).
- Participated in other clinical trials within the last 3 months.
- Had known allergy or hypersensitivity to the components of the investigational product.
- Were pregnant or nursing.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Bjørge Øre-Nese-Hals
Ålesund, 6003
Haukeland Universitetssykehus, Departments of Otolaryngology and Head and Neck Surgery, Helse Bergen
Bergen, 5021
Stortorget Øre Nese Hals AS
Hamar, 2317
Hov Legesenter
Hov, 2860
Sørlandet Sykehus, Kristiansand, Department for Ear, Nose and Throat
Kristiansand, 4615
Heiaklinikken Legesenter, Helsehuset Lierskogen
Lierskogen, 3420
Stavanger Øre-Nese-Hals
Stavanger, 4020
About this study
Official title: A Prospective, Randomised, Double-blind, Multicentre Parallel-group Study Comparing a Medical Device: Proponent Solution - Nasal Spray (PSNS) With Comparator (Sodium Chloride 0.9%) for Treatment of Nasal Congestion Symptoms (in Adults) During Rhinitis Medicamentosa While Weaning From Direct-acting Alpha-adrenergic Agonists, Such as Xylometazoline or Oxymetazoline
The purpose of the study was to test if the PROPONENT® nasal spray works, if it is safe, and if it helps participants to stop using addictive nasal decongestant sprays. To be able to take part in the study, participants had to be at least 18 years old, suffer from a condition called "rebound nasal congestion" or "rhinitis medicamentosa (RM)", and be dependent on nasal decongestants. Participants were randomly assigned to receive either PROPONENT® nasal spray or a nasal spray with physiological saline during the 4-week study treatment period. Neither the participants nor their doctor knew which they were receiving. In total, 194 participants took part in this study in several hospitals in Norway.
The study included three visits to the study center: one at the beginning and one at the end of the treatment period, and a follow-up visit approximately 4 weeks after the end of study treatment. During the study treatment period, participants used 1-2 puffs of study nasal spray in each nostril in the morning and evening. They could use the nasal spray additional times if they felt the need due to nasal congestion, up to a maximum of 16 puffs a day. During they study treatment period, participants were asked to measure every morning and evening how much air they could maximally inhale through their nose using a simple instrument called Peak Nasal Inspiratory Flow (PNIF) meter. At the end of each week of the treatment period, participants were asked to report how bad their nasal problems had been during the past week using electronic questionnaires. At the follow-up visit, participants were asked if they could still manage without the decongestant nasal sprays they had been using before entering the study, and if they felt that they had become addicted to the study nasal spray.
Read the detailed description
This was a prospective, randomised, double-blind, multicenter, parallel-group study to evaluate Proponent Solution - Nasal Spray (PSNS) compared to sodium chloride 0.9% (Isotonic Saline Nasal Spray [ISNS]) for treatment of nasal congestion symptoms during RM while weaning from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline. The study aimed to recruit approximately 200 subjects (actual: 194 subjects) who should receive 4 weeks of treatment with PSNS or ISNS to evaluate the efficacy, safety, and tolerability.
Before study start, prospective subjects received a telephone call by the study personnel where they were informed about the study and asked to make notes of their daily use of xylometazoline or oxymetazoline each evening (including the number of doses used) for 7 days prior to start of study treatment. This data was transferred to an electronic diary (eDiary) for all subjects that were included in the study. Prospective subjects attended an enrolment visit (Visit 1) at the investigational site, where informed consent was discussed and signed. Eligible subjects were randomised (1:1) to receive the investigational device product (PSNS) or the comparator (ISNS), and self-administered the first dose of study treatment under supervision of the study personnel.
During the 4-week treatment period (28 days, -1 to +5 days), subjects self-administered the study nasal spray at a maximum dose of 16 puffs per day distributed over 1-2 puffs applied into each nostril 2-4 times daily. Subjects were asked to report daily their objective morning and evening PNIF meter results in an eDiary on a smartphone or laptop both before and 10 minutes after administration of 1-2 puffs of either PSNS or the comparator. Each week, subjects had to fill out electronic questionnaires assessing their nasal congestion/obstruction using validated scoring systems (NOSE and NOVAS-score). At 21-35 days after the end of study treatment (Visit 3), each subject was asked to complete a follow-up registration in the eDiary. During this assessment, it was also assessed whether the subject had become addicted to/physically dependent on the study nasal spray.
- Conditions
- Rhinitis Medicamentosa
- Being tested
- PSNS, ISNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSNSDevice
The nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation.
ISNSDevice
The nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation.
| Study group | Role | What they receive |
|---|---|---|
| PSNS | Experimental | The PSNS consisted of a Locke-Ringer solution containing 10 mg/mL sodium propionate. The solution was provided in a microbiologically safeguarded, multi-use dosing system consisting of a plastic storage bottle (20 mL) and a nasal applicator. The nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation. Each puff contained approximately 140 µl nasal spray solution. Receives: Device: PSNS |
| ISNS | Placebo comparator | The comparator ISNS consisted of water containing 0.9% w/v sodium chloride. The ISNS solution was provided in the same microbiologically safeguarded, multi-use dosing system as the investigational device product. The nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation. Each puff contained approximately 140 µl nasal spray solution. Receives: Device: ISNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who did not use xylometazoline or oxymetazoline nasal spray for three consecutive days at the end of the clinical study treatment period (PSNS vs ISNS)
Measured: Day 0 (randomisation, start of treatment) until end of treatment (Day 28, -1 day until + 5 days)
Secondary outcomes (7)
At least a 50% reduction in the use of xylometazoline or oxymetazoline nasal spray for three consecutive days at the end of the study treatment period compared to the use reported before study start (PSNS vs ISNS)
This was based on the self-reported use of xylometazoline/oxymetazoline.
Measured: Day 0 (randomisation, start of treatment) until end of treatment (Day 28, -1 day until + 5 days)
Peak Nasal Inspiratory Flow (PNIF)-score measured in the last week of the study treatment period
The PNIF meter is a lightweight and compact instrument that provides an objective result of nasal patency. Study subjects were asked to take three repeated PNIF measurements at each time point, and to record the highest result in their eDiary. The PNIF score was measured in litres per minute (L/min). Values above 125 L/min were considered out-of-range. Higher values indicate better nasal patency.
Measured: Last week of the study treatment period (Day 27-33)
NOVAS-score measured in the last week of the study treatment period
This was assessed using the validated questionnaire Nasal Obstruction Visual Analogue Scale (NOVAS). The scale ranges from 0 to 10, where 0 corresponds to "no nasal obstruction" and 10 corresponds to "maximum nasal obstruction".
Measured: Last week of the study treatment period (Day 27-33)
NOSE-score measured in the last week of the study treatment period
This was assessed using the validated questionnaire Nasal Obstruction Symptom Evaluation (NOSE). The total score ranges from 0 to 20, and a higher score indicates more severe nasal obstruction.
Measured: Last week of the study treatment period (Day 27-33)
Temporal trends in PNIF-score during the study treatment period
The PNIF meter is a lightweight and compact instrument that provides an objective result of nasal patency. Study subjects were asked to take three repeated PNIF measurements at each time point, and to record the highest result in their eDiary. The PNIF score was measured in L/min. Values above 125 L/min were considered out-of-range. Higher values indicate better nasal patency.
Measured: From randomisation to end of study treatment (Day 27-33)
Temporal trends in NOVAS-score during the study treatment period
This was assessed using the validated questionnaire Nasal Obstruction Visual Analogue Scale (NOVAS). The scale ranges from 0 to 10, where 0 corresponds to "no nasal obstruction" and 10 corresponds to "maximum nasal obstruction".
Measured: From randomisation to end of study treatment (Day 27-33)
Temporal trends in NOSE-score during the study treatment period
This was assessed using the validated questionnaire Nasal Obstruction Symptom Evaluation (NOSE). The total score ranges from 0 to 20, and a higher score indicates more severe nasal obstruction.
Measured: From randomisation to end of study treatment (Day 27-33)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start25 Feb 2024
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis MedicamentosaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective, randomised, double-blind, multicentre, parallel-group study to evaluate Proponent Solution - Nasal Spray (PSNS) compared to Isotonic Saline Nasal Spray (ISNS) for treatment of nasal congestion symptoms in adult subjects with RM while weaning from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline. The study aimed to recruit approximately 200 subjects (actual: 194 subjects) who should receive 4-weeks (28 days, 1 to +5 days) of treatment with PSNS or ISNS, to evaluate the efficacy, safety, and tolerability.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharma Nordic AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Proponent Biotech GmbH
- Responsible party
- Sponsor
- Investigators
- Kjetil Høye, MD, Study director, Pharma Nordic AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817967
- Sponsor's protocol ID
- PROUD study
- Acronym
- PROUD
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Double-blind, Multicentre Parallel-group Study Comparing a Medical Device: Proponent Solution - Nasal Spray (PSNS) With Comparator (Sodium Chloride 0.9%) for Treatment of Nasal Congestion Symptoms (in Adults) During Rhinitis Medicamentosa While Weaning From Direct-acting Alpha-adrenergic Agonists, Such as Xylometazoline or Oxymetazoline
- ClinicalTrials.gov ID
- NCT06817967
- Acronym / sponsor ID
- PROUD / PROUD study
- Conditions
- Rhinitis Medicamentosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Pharma Nordic ASIndustry (pharma, biotech, devices)
- Collaborators
- Proponent Biotech GmbH
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 10 Feb 2025 (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.
The purpose of the study was to test if the PROPONENT® nasal spray works, if it is safe, and if it helps participants to stop using addictive nasal decongestant sprays. To be able to take part in the study, participants had to be at least 18 years old, suffer from a condition called "rebound nasal congestion" or "rhinitis medicamentosa (RM)", and be dependent on nasal decongestants. Participants were randomly assigned to receive either PROPONENT® nasal spray or a nasal spray with physiological saline during the 4-week study treatment period. Neither the participants nor their doctor knew which they were receiving. In total, 194 participants took part in this study in several hospitals in Norway.
The study included three visits to the study center: one at the beginning and one at the end of the treatment period, and a follow-up visit approximately 4 weeks after the end of study treatment. During the study treatment period, participants used 1-2 puffs of study nasal spray in each nostril in the morning and evening. They could use the nasal spray additional times if they felt the need due to nasal congestion, up to a maximum of 16 puffs a day. During they study treatment period, participants were asked to measure every morning and evening how much air they could maximally inhale through their nose using a simple instrument called Peak Nasal Inspiratory Flow (PNIF) meter. At the end of each week of the treatment period, participants were asked to report how bad their nasal problems had been during the past week using electronic questionnaires. At the follow-up visit, participants were asked if they could still manage without the decongestant nasal sprays they had been using before entering the study, and if they felt that they had become addicted to the study nasal spray.
Detailed description
This was a prospective, randomised, double-blind, multicenter, parallel-group study to evaluate Proponent Solution - Nasal Spray (PSNS) compared to sodium chloride 0.9% (Isotonic Saline Nasal Spray [ISNS]) for treatment of nasal congestion symptoms during RM while weaning from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline. The study aimed to recruit approximately 200 subjects (actual: 194 subjects) who should receive 4 weeks of treatment with PSNS or ISNS to evaluate the efficacy, safety, and tolerability.
Before study start, prospective subjects received a telephone call by the study personnel where they were informed about the study and asked to make notes of their daily use of xylometazoline or oxymetazoline each evening (including the number of doses used) for 7 days prior to start of study treatment. This data was transferred to an electronic diary (eDiary) for all subjects that were included in the study. Prospective subjects attended an enrolment visit (Visit 1) at the investigational site, where informed consent was discussed and signed. Eligible subjects were randomised (1:1) to receive the investigational device product (PSNS) or the comparator (ISNS), and self-administered the first dose of study treatment under supervision of the study personnel.
During the 4-week treatment period (28 days, -1 to +5 days), subjects self-administered the study nasal spray at a maximum dose of 16 puffs per day distributed over 1-2 puffs applied into each nostril 2-4 times daily. Subjects were asked to report daily their objective morning and evening PNIF meter results in an eDiary on a smartphone or laptop both before and 10 minutes after administration of 1-2 puffs of either PSNS or the comparator. Each week, subjects had to fill out electronic questionnaires assessing their nasal congestion/obstruction using validated scoring systems (NOSE and NOVAS-score). At 21-35 days after the end of study treatment (Visit 3), each subject was asked to complete a follow-up registration in the eDiary. During this assessment, it was also assessed whether the subject had become addicted to/physically dependent on the study nasal spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This was a prospective, randomised, double-blind, multicentre, parallel-group study to evaluate Proponent Solution - Nasal Spray (PSNS) compared to Isotonic Saline Nasal Spray (ISNS) for treatment of nasal congestion symptoms in adult subjects with RM while weaning from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline. The study aimed to recruit approximately 200 subjects (actual: 194 subjects) who should receive 4-weeks (28 days, 1 to +5 days) of treatment with PSNS or ISNS, to evaluate the efficacy, safety, and tolerability.
| Arm | Type | Receives |
|---|---|---|
| PSNS | Experimental | Device: PSNSThe PSNS consisted of a Locke-Ringer solution containing 10 mg/mL sodium propionate. The solution was provided in a microbiologically safeguarded, multi-use dosing system consisting of a plastic storage bottle (20 mL) and a nasal applicator. The nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation. Each puff contained approximately 140 µl nasal spray solution. |
| ISNS | Placebo comparator | Device: ISNSThe comparator ISNS consisted of water containing 0.9% w/v sodium chloride. The ISNS solution was provided in the same microbiologically safeguarded, multi-use dosing system as the investigational device product. The nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation. Each puff contained approximately 140 µl nasal spray solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide signed informed consent prior to any study-specific procedures.
- Be 18 years of age or older.
- Use xylometazoline or oxymetazoline nasal spray at least once daily over a period of 7 days, registered before entering the clinical study.
- Be diagnosed with RM by a medical doctor. The subject needed/wanted to wean from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline.
Key exclusion criteria (13 listed)
- Had influenza, acute or chronic rhinitis (other than RM), acute sinusitis, suppurative tonsillitis, pneumonia, or tuberculosis.
- Had taken any medication or cold remedies to treat common colds (including Proponent Solution - Nasal Spray [PSNS]) within the last week.
- Had used glucocorticoids (tablets, injections, and topical inhalers) within the last week or will need this medication during the study.
- Had serious primary cardiovascular, kidney, liver, neurological, psychiatric, or haematological disease.
- Had a diagnosis of asthma, chronic obstructive pulmonary disease, chronic cough, or other significant acute or chronic respiratory conditions or disorders.
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 |
|---|---|---|
| PSNSThe nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation. | Device | PSNS |
| ISNSThe nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation. | Device | ISNS |
Primary outcome
Proportion of subjects who did not use xylometazoline or oxymetazoline nasal spray for three consecutive days at the end of the clinical study treatment period (PSNS vs ISNS)
Time frame: Day 0 (randomisation, start of treatment) until end of treatment (Day 28, -1 day until + 5 days)
7 secondary outcomes
At least a 50% reduction in the use of xylometazoline or oxymetazoline nasal spray for three consecutive days at the end of the study treatment period compared to the use reported before study start (PSNS vs ISNS)
Time frame: Day 0 (randomisation, start of treatment) until end of treatment (Day 28, -1 day until + 5 days)
Peak Nasal Inspiratory Flow (PNIF)-score measured in the last week of the study treatment period
Time frame: Last week of the study treatment period (Day 27-33)
NOVAS-score measured in the last week of the study treatment period
Time frame: Last week of the study treatment period (Day 27-33)
NOSE-score measured in the last week of the study treatment period
Time frame: Last week of the study treatment period (Day 27-33)
Temporal trends in PNIF-score during the study treatment period
Time frame: From randomisation to end of study treatment (Day 27-33)
Temporal trends in NOVAS-score during the study treatment period
Time frame: From randomisation to end of study treatment (Day 27-33)
Temporal trends in NOSE-score during the study treatment period
Time frame: From randomisation to end of study treatment (Day 27-33)
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 25 Apr 2025.
- Individual participant dataSharing planned: No
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.
Kjetil Høye, MD study director
Pharma Nordic AS
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSNS and ISNS in people with Rhinitis Medicamentosa, run by Pharma Nordic AS at 7 sites in Norway.
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 13 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 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. 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. 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.
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?
Proportion of subjects who did not use xylometazoline or oxymetazoline nasal spray for three consecutive days at the end of the clinical study treatment period (PSNS vs ISNS) (time frame: Day 0 (randomisation, start of treatment) until end of treatment (Day 28, -1 day until + 5 days)). 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 25 Apr 2025.