Laryngopharyngeal RefluxPhase 4NCT03086070
Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis
A Phase 4 study testing Omeprazole 20mg in people with Laryngopharyngeal Reflux and Chronic Rhinosinusitis (Diagnosis), run by Children's Hospital Srebrnjak.
Trial summary
The hypothesis of this study is that a gastroesophageal reflux recommended treatment with proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngopharyngeal Reflux, Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Omeprazole 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Jun 2010
- Phase
- Phase 4
- 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
- laryngopharyngeal reflux
- chronic rhinosinusitis
Who cannot join
- allergic rhinitis
- asthma
- cystic fibrosis
- nasal polyposis
- severe systemic diseases
About this study
Official title: Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis - a Randomized, Double Blind, Placebo Controlled Trial
The hypothesis of this study is that a gastroesophageal reflux recommended treatment with proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis. Primary objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (OD) significantly reduces the signs and symptoms of laryngopharyngeal reflux when compared to placebo in patients with laryngopharyngeal reflux with comorbid chronic rhinosinusitis. Secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg OD significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients with laryngopharyngeal reflux when compared to matching placebo; and to investigate the association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis in the same group of patients. The research was carried out as a double blind randomized placebo controlled trial. Patients were randomized into two groups in an approximate 1:1 ratio using a concealed random sequence. After randomization and initial assessment treatment was initialized. Patients on active treatment were given omeprazole 20 mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group were given matching placebo tablets using the same regimen for 8 weeks as the group on the active treatment. Patients were reassessed at the end of treatment for signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis.
- Being tested
- Omeprazole 20mg, Placebo oral capsule
- Keywords
- omeprazole, placebo, treatment, adults
- Medical subject headings
- Laryngopharyngeal Reflux, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole 20mgDrug
omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks
Placebo oral capsuleDrug
Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | omeprazole 20 mg capsule once daily for 8 weeks Receives: Drug: Omeprazole 20mg |
| Placebo arm | Placebo comparator | matching placebo capsules ones daily for 8 weeks Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in signs and symptoms of laryngopharyngeal reflux
Reflux symptom index (RSI) score
Measured: 8 weeks
Reduction in signs and symptoms of laryngopharyngeal reflux
Reflux finding score (RFS)
Measured: 8 weeks
Secondary outcomes (2)
Reduction of signs and symptoms of comorbid chronic rhinosinusitis
Nasal obstruction, anterior/posterior nasal drip, headache, sneezing, cough, smell and taste disorder with frequency and intensity of the symptoms was graded from 0 (no problem) to 3 (severe problem).
Nasal endoscopy with endoscopy scores were based on the assessment of nasal mucosa edema, secretions and presence of polyps and were graded from 0 (no problem) to 3 (severe problem).
Measured: 8 weeks
Association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis
Measured: Baseline and after 8 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Jan 2010
- Primary completion30 Apr 2010
- Study completion30 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngopharyngeal RefluxStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double blind, placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Srebrnjak
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Center Sisters of Charity, Zagreb, Croatia, Belupo
- Responsible party
- Principal investigator, Davor Plavec, Children's Hospital Srebrnjak
- Investigators
- Srđan A Anzić, MD, PhD, Principal investigator, Children's Hospital Srebrnjak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086070
- Sponsor's protocol ID
- CHS-ENT01
- Status last verified
- Dec 2020
- First submitted
- 6 Mar 2017
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised individual participant data can be obtained for other researchers on a written request to the principal investigator.
Publications
Anzic SA, Turkalj M, Zupan A, Labor M, Plavec D, Baudoin T. Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: Randomised, double-blind, placebo-controlled trial. Clin Otolaryngol. 2018 Apr;43(2):496-501. doi: 10.1111/coa.13005. Epub 2017 Oct 23.
PubMed 29024410
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis - a Randomized, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03086070
- Acronym / sponsor ID
- CHS-ENT01
- Keywords
- omeprazole, placebo, treatment, adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital SrebrnjakUniversity, hospital or other
- Collaborators
- University Hospital Center Sisters of Charity, Zagreb, Croatia, Belupo
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Apr 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 22 Mar 2017 (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.
The hypothesis of this study is that a gastroesophageal reflux recommended treatment with proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis. Primary objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (OD) significantly reduces the signs and symptoms of laryngopharyngeal reflux when compared to placebo in patients with laryngopharyngeal reflux with comorbid chronic rhinosinusitis. Secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg OD significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients with laryngopharyngeal reflux when compared to matching placebo; and to investigate the association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis in the same group of patients. The research was carried out as a double blind randomized placebo controlled trial. Patients were randomized into two groups in an approximate 1:1 ratio using a concealed random sequence. After randomization and initial assessment treatment was initialized. Patients on active treatment were given omeprazole 20 mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group were given matching placebo tablets using the same regimen for 8 weeks as the group on the active treatment. Patients were reassessed at the end of treatment for signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double blind, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Omeprazole 20mgomeprazole 20 mg capsule once daily for 8 weeks |
| Placebo arm | Placebo comparator | Drug: Placebo oral capsulematching placebo capsules ones daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- laryngopharyngeal reflux
- chronic rhinosinusitis
Key exclusion criteria (5 listed)
- allergic rhinitis
- asthma
- cystic fibrosis
- nasal polyposis
- severe systemic diseases
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 |
|---|---|---|
| Omeprazole 20mgomeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks | Drug | Treatment arm |
| Placebo oral capsuleMatching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks | Drug | Placebo arm |
Primary outcome
Reduction in signs and symptoms of laryngopharyngeal reflux
Time frame: 8 weeks
Reflux symptom index (RSI) score
Reduction in signs and symptoms of laryngopharyngeal reflux
Time frame: 8 weeks
Reflux finding score (RFS)
2 secondary outcomes
Reduction of signs and symptoms of comorbid chronic rhinosinusitis
Time frame: 8 weeks
Association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis
Time frame: Baseline and after 8 weeks of treatment.
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 30 Dec 2020.
- Results publication: PubMed 29024410Anzic SA, Turkalj M, Zupan A, Labor M, Plavec D, Baudoin T. Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: Randomised, double-blind, placebo-controlled trial. Clin Otolaryngol. 2018 Apr;43(2):496-501. doi: 10.1111/coa.13005. Epub 2017 Oct 23.
- Individual participant dataSharing planned: No. Anonymised individual participant data can be obtained for other researchers on a written request to the principal investigator.
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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.
Srđan A Anzić, MD, PhD principal investigator
Children's Hospital Srebrnjak
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole 20mg in people with Laryngopharyngeal Reflux and Chronic Rhinosinusitis (Diagnosis), run by Children's Hospital Srebrnjak.
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 2 inclusion and 5 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in signs and symptoms of laryngopharyngeal reflux (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086070, which also lists 1 linked publication.
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 30 Dec 2020.