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

Summary

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.

Conditions

• Chronic Cough (CC)
• Upper Airway Cough Syndrome
• Chronic Rhinitis

Interventions

DRUG

Budesonide (400μg/d)

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.

DRUG

Mometasone Furoate 50mcg Nasal Spray

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.

Sponsors & Collaborators

• Silesian University of Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2026-07-30

Completion

2026-07-30

Countries

• Poland

Study Locations