Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis (NCT00903227) | Clinical Trial Compass
CompletedPhase 4
Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis
United Kingdom25 participantsStarted 2006-12
Plain-language summary
Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves quality of life. While there is evidence that combined treatment of the nose and the lungs with topical steroids improves symptoms and underlying inflammation, it is unclear whether such control can be achieved using a smaller dose of inhaled steroid in combination with nasal steroid. It is therefore the intention of this study to evaluate if combination steroid therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis using sensitive markers of airway inflammation.
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:
* Mild to moderate atopic asthmatics with FEV1 ≥ 60% on ≤ 1000 ug BDP and concomitant persistent allergic rhinitis (SPT +ve and PC20 \< 4 mg/ml)
* Male or female aged 18-65 years
* Informed Consent
* Ability to comply with the requirements of the protocol
Exclusion Criteria:
* Severe asthmatics as defined by an FEV1 ≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
* Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
* The use of oral corticosteroids within the last 3 months
* Recent respiratory tract infection (2 months)
* Significant concomitant respiratory disease
* Any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol
* Any significant abnormal laboratory result as deemed by the investigators
* Pregnancy, planned pregnancy or lactation
* Known or suspected contra-indication to any of the IMP's
* Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial
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.