Comparison of the Efficacy of Two Therapeutic Regimens in Patients With Chronic Cough With Signs of Rhinitis or Paranasal Sinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 4 weeks
研究概览
简要总结
Chronic cough - a cough lasting eight weeks or longer - is one of the most common reasons people see a lung specialist. It can disturb sleep, make conversation difficult, and reduce quality of life.
In many people, chronic cough occurs together with nose and sinus symptoms such as a blocked or runny nose, mucus dripping down the back of the throat, facial pain, or a reduced sense of smell. This combination is often called upper airway cough syndrome. Doctors commonly treat it with a steroid medicine given either as an inhaler breathed into the lungs or as a spray into the nose. Both are approved, widely used medicines, and treatment guidelines mention both. However, no study has directly compared the two to see whether one relieves cough better than the other, so doctors have little evidence to guide the choice.
This study compares the two treatments directly in adults who have chronic cough together with nose or sinus symptoms. Participants are assigned by chance, like flipping a coin, to one of two groups:
an inhaled steroid (budesonide), breathed in twice a day, or a steroid nasal spray (mometasone furoate), sprayed into each nostril twice a day.
Participants use their assigned treatment for 4 weeks and then return to the clinic. At each visit they rate how severe their cough is by marking a line on a 100-millimetre scale, and they fill in a questionnaire about how the cough affects their daily life.
Participants whose cough has cleared up after 4 weeks finish the study at that point. Those whose cough has not cleared up continue for another 4 weeks: people in the inhaler group carry on with the same inhaler, while people in the nasal spray group continue the spray and also start the inhaler. Everyone who continues returns for a final visit at 8 weeks.
The main question is whether the inhaled steroid reduces cough severity more than the nasal spray after 4 weeks of treatment. The study also looks at cough-related quality of life, and at what happens after treatment is adjusted at 4 weeks.
The study takes place at a single outpatient lung clinic in Katowice, Poland. Both medicines are given at their usual approved doses, and participants are otherwise cared for as in routine practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic cough and signs of chronic upper airway disease
排除标准
- •Symptoms of an acute respiratory tract infection within 4 weeks prior to enrolment.
- •Diagnosis of any active chronic respiratory disease.
- •Diagnosis of other cause of chronic cough.
- •Use of corticosteroids (oral, intranasal, inhaled, intravenous) within 3 months prior to enrolment.
- •Chronic use of angiotensin-converting enzyme (ACE) inhibitors within 1 month prior to enrolment.
- •Smoking of tobacco products within 6 months prior to enrolment
- •Pregnancy.
研究组 & 干预措施
Inhaled corticosteroids group
Participants receive inhaled budesonide 400 µg per dose, two doses twice daily (800 µg per administration; 1600 µg total daily), for 4 weeks. Cough severity is assessed at the 4-week visit. Participants reaching a Visual Analog Scale score of 10 mm or lower are classified as having achieved cough resolution and complete the study at this point. Participants not reaching this threshold continue inhaled budesonide unchanged at the same dose for a further 4 weeks, to a total of 8 weeks, with a final assessment at week 8.
干预措施: Budesonide (400μg/d) (Drug)
Intranasal(+inhaled) corticosteroids group
Participants receive intranasal mometasone furoate 50 µg per dose, two doses into each nostril twice daily (100 µg per nostril per administration; 400 µg total daily), for 4 weeks. Cough severity is assessed at the 4-week visit. Participants reaching a Visual Analog Scale score of 10 mm or lower are classified as having achieved cough resolution and complete the study at this point. Participants not reaching this threshold continue intranasal mometasone furoate at the same dose with inhaled budesonide 400 µg per dose, two doses twice daily, added for a further 4 weeks, to a total of 8 weeks, with a final assessment at week 8. Beyond week 4 this arm therefore receives combined intranasal and inhaled corticosteroid therapy rather than intranasal monotherapy.
干预措施: Mometasone Furoate 50mcg Nasal Spray (Drug)
Intranasal(+inhaled) corticosteroids group
Participants receive intranasal mometasone furoate 50 µg per dose, two doses into each nostril twice daily (100 µg per nostril per administration; 400 µg total daily), for 4 weeks. Cough severity is assessed at the 4-week visit. Participants reaching a Visual Analog Scale score of 10 mm or lower are classified as having achieved cough resolution and complete the study at this point. Participants not reaching this threshold continue intranasal mometasone furoate at the same dose with inhaled budesonide 400 µg per dose, two doses twice daily, added for a further 4 weeks, to a total of 8 weeks, with a final assessment at week 8. Beyond week 4 this arm therefore receives combined intranasal and inhaled corticosteroid therapy rather than intranasal monotherapy.
干预措施: Budesonide (400μg/d) (Drug)
结局指标
主要结局
Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 4 weeks
时间窗: After 4 weeks of treatment
Cough severity is self-rated by the participant on a 100-mm visual analog scale ranging from 0 mm ("no cough") to 100 mm ("worst cough"); higher scores indicate more severe cough. The 4-week score is compared between arms by analysis of covariance with the baseline VAS score as covariate, and reported as an adjusted between-group difference with a 95% confidence interval.
Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 4 weeks
时间窗: Baseline and week 4
Cough severity is self-rated by the participant on a 100-mm visual analog scale ranging from 0 mm ("no cough") to 100 mm ("worst cough"); higher scores indicate more severe cough. The 4-week score is compared between arms by analysis of covariance with the baseline VAS score as covariate, and reported as an adjusted between-group difference with a 95% confidence interval.
次要结局
- Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 8 weeks(After 8 weeks of treatment)
- Change from baseline in cough-related quality of life measured by Leicester Cough Questionnaire (LCQ) total score(Baseline, 4 weeks and 8 weeks)
- Proportion of participants achieving therapeutic success(4 weeks and 8 weeks)
- Proportion of participants achieving cough resolution(4 weeks and 8 weeks)
- Change from baseline in Leicester Cough Questionnaire (LCQ) domain scores(Baseline, 4 weeks and 8 weeks)
- Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 8 weeks(Baseline and week 8)
研究者
Maciej Ogonowski
Mr
Silesian University of Medicine