Inhaled vs Intranasal Corticosteroids for Chronic Cough in Upper Airway Cough Syndrome

Silesian University of Medicine56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

Budesonide (400μg/d)DRUG

Inhaled budesonide 400 µg per dose, two doses twice daily (800 µg per administration; 1600 µg total daily), administered by inhaler. In the inhaled corticosteroid arm it is given from randomization as monotherapy for 4 weeks, and continued unchanged at the same dose for a further 4 weeks in participants who have not achieved cough resolution. In the intranasal corticosteroid arm it is added to ongoing intranasal mometasone furoate at week 4 in participants who have not achieved cough resolution, and given for 4 weeks. Maximum total duration of exposure is 8 weeks.

Mometasone Furoate 50mcg Nasal SprayDRUG

Intranasal mometasone furoate 50 µg per dose, two doses into each nostril twice daily (100 µg per nostril per administration; 400 µg total daily), administered by nasal spray. Given from randomization for 4 weeks. Participants who have not achieved cough resolution at 4 weeks continue it at the same dose for a further 4 weeks with inhaled budesonide added. Maximum total duration of exposure is 8 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with chronic cough and signs of chronic upper airway disease Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 4 weeks

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.

Time frame: Baseline and week 4

Secondary Outcomes

Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 8 weeks

Cough severity self-rated on the 100-mm VAS (0 mm = no cough, 100 mm = worst cough; higher scores indicate more severe cough), analysed by the same ANCOVA model as the primary outcome.

Time frame: Baseline and week 8

Change from baseline in cough-related quality of life measured by Leicester Cough Questionnaire (LCQ) total score

The LCQ is a 19-item self-completed questionnaire assessing the impact of cough over the previous 2 weeks across three domains (physical, psychological, social). Each item is scored 1 to 7; the total score is the sum of the three domain means and ranges from 3 to 21, with higher scores indicating better cough-related quality of life. An improvement of 1.3 points is the published minimal important difference.

Time frame: Baseline, 4 weeks and 8 weeks

Proportion of participants achieving therapeutic success

Therapeutic success is defined as a reduction from baseline of 30 mm or more on the 100-mm cough severity VAS, corresponding to the published minimal clinically important difference. Compared between arms with Fisher's exact test and reported as a risk difference with a 95% confidence interval. Exploratory.

Time frame: 4 weeks and 8 weeks

Proportion of participants achieving cough resolution

Cough resolution is defined as a cough severity VAS score of 10 mm or lower. Participants meeting this threshold at 4 weeks complete the study at that visit. Compared between arms with Fisher's exact test and reported as a risk difference with a 95% confidence interval. Exploratory.

Time frame: 4 weeks and 8 weeks

Change from baseline in Leicester Cough Questionnaire (LCQ) domain scores

LCQ physical (8 items), psychological (7 items) and social (4 items) domain scores, each expressed as the mean of its constituent items on a 1 to 7 scale, with higher scores indicating better cough-related quality of life. Published minimal important differences are 0.8 (physical), 0.9 (psychological) and 0.8 (social).