Chronic Cough (CC)NCT07777796
Inhaled vs Intranasal Corticosteroids for Chronic Cough in Upper Airway Cough Syndrome
A study testing Budesonide (400μg/d) and Mometasone Furoate 50mcg Nasal Spray in people with Chronic Cough (CC) and Upper Airway Cough Syndrome, run by Silesian University of Medicine at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cough (CC), Upper Airway Cough Syndrome, Chronic Rhinitis
- What is being tested?
- Budesonide (400μg/d) and Mometasone Furoate 50mcg Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2022to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic cough and signs of chronic upper airway disease
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Leszek Giec Upper-Silesian Medical Centre of the Medical University of Silesia
Katowice, Silesian Voivodeship, 40-635
About this study
Official title: Comparison of the Efficacy of Two Therapeutic Regimens in Patients With Chronic Cough With Signs of Rhinitis or Paranasal Sinusitis
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.
Read more
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.
- Being tested
- Budesonide (400μg/d), Mometasone Furoate 50mcg Nasal Spray
- Keywords
- chronic cough, Upper airway cough syndrome, inhaled corticosteroids, intranasal corticosteroids
- Medical subject headings
- Chronic Cough, upper airway cough syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled corticosteroids group | Active comparator | 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. Receives: Drug: Budesonide (400μg/d) |
| Intranasal(+inhaled) corticosteroids group | Experimental | 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. Receives: Drug: Budesonide (400μg/d); Drug: Mometasone Furoate 50mcg Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jul 2022
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cough (CC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silesian University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Ogonowski, Silesian University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777796
- Sponsor's protocol ID
- PCN/CBN/0052/KB1/73/22
- Other IDs
- BNW-1-049/K/3/K, BNW-1-169/K/4/K
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Two Therapeutic Regimens in Patients With Chronic Cough With Signs of Rhinitis or Paranasal Sinusitis
- ClinicalTrials.gov ID
- NCT07777796
- Acronym / sponsor ID
- PCN/CBN/0052/KB1/73/22
- Keywords
- chronic cough, Upper airway cough syndrome, inhaled corticosteroids, intranasal corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Silesian University of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled corticosteroids group | Active comparator | Drug: Budesonide (400μg/d)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. |
| Intranasal(+inhaled) corticosteroids group | Experimental | Drug: Budesonide (400μg/d), Drug: Mometasone Furoate 50mcg Nasal SprayParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic cough and signs of chronic upper airway disease
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Inhaled corticosteroids group, Intranasal(+inhaled) corticosteroids group |
| Mometasone Furoate 50mcg Nasal SprayIntranasal 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. | Drug | Intranasal(+inhaled) corticosteroids group |
Primary outcome
Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 4 weeks
Time frame: 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.
5 secondary outcomes
Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 8 weeks
Time frame: Baseline and week 8
Change from baseline in cough-related quality of life measured by Leicester Cough Questionnaire (LCQ) total score
Time frame: Baseline, 4 weeks and 8 weeks
Proportion of participants achieving therapeutic success
Time frame: 4 weeks and 8 weeks
Proportion of participants achieving cough resolution
Time frame: 4 weeks and 8 weeks
Change from baseline in Leicester Cough Questionnaire (LCQ) domain scores
Time frame: Baseline, 4 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide (400μg/d) and Mometasone Furoate 50mcg Nasal Spray in people with Chronic Cough (CC) and Upper Airway Cough Syndrome, run by Silesian University of Medicine at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 4 weeks (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.