Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of… (NCT05080322) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis
China150 participantsStarted 2021-09-09
Plain-language summary
WHO recommend to divide AR into 4 subgroups according to the symptom frequency (intermittent or persistent) and severity (mild or moderate-to-severe). For the persistent moderate-to-severe AR subgroup, the guideline suggests to treat with intranasal corticosteroid (INS) plus antihistamines (AH1) for 2-4 weeks. If the symptom is controlled then degrade the treatment (usually with INS) and maintenance for more than 4 weeks. However, up to 70% of patients suffering from AR do not follow treatment recommendation, they stopped medication when they feel better. This behavior always leads to uncontrolled AR, which has been identified as a high-risk factor of induction and exacerbation of asthma and chronic rhinosinusitis. A recent survey showed that AR patients prefer to an on-demand treatment rather than continuous treatment. In general, poor adherence is always a considerable issue for all long-term treatments. Previous studies have shown that as dosing frequency increases, the adherence rate decreases. Thus, less medication frequency is an important factor to optimize the management of chronic diseases including AR.
Intranasal AH1 can relieve AR symptoms including sneezing, rhinorrhea and nasal itching in 3 to 5 minutes, while INS can inhibit the underlying mucous allergic inflammation and is recommended as the first-line medication for moderate-to-severe AR. INS combined AH1 have shown a synergic effect on control AR inflammation and provide rapid AR symptom relief. Investigators hypothesis that the on-demand administration of INS combined AH1 can achieve similar AR control level with less dosing frequency as compared to the daily INS maintenance in controlled moderate-to-severe AR patients.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-65 years old
* AR patients (according to ARIA guidelines)
* Mono-sensitized to HDM and had AR symptoms after HDM exposure;
* Participants had at least 2 nasal symptoms(sneezing, runny nose, itching, nasal congestion) in the screening period
* ARCT score ≥20 after 2-week INS combined with AH1 treatment at run-in period
* had adequent informed and given their consent to participate in the study.
Exclusion Criteria:
* Pregnant or lactating women, patients with malignant tumor, patients with congenital or acquired immunodeficiency disease, patients with mental illness
* Acute upper respiratory infection in the run-in period
* History of chronic sinusitis with nasal polyps
* Severe deviation of nasal septum
* received allergen immunotherapy in the past 5 years
* received biological therapy in the past 6 months
* Acute upper respiratory tract infection in run-in period
* Patients who failed to achieve AR control in the run-in period
* Patients who are participating in other clinical trials
* patients who are not suitable for this clinical trial due to other reasons (evaluated by investigators).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AR control level after 4-week treatment among the three groups with different treatment