Nasal PolypsPhase 4NCT00788749
Medical Polypectomy and Predictors of Response
A Phase 4 study testing Prednisolone, fluticasone nasal drops and fluticasone nasal spray in people with Nasal Polyps, run by University of Dundee at 1 site in United Kingdom.
Trial summary
This is the first randomized parallel group clinical trial looking at oral prednisolone induced medical nasal polypectomy followed by maintenance on topical steroid therapy in patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and the factors linking nasal polyps with asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Prednisolone, fluticasone nasal drops and fluticasone nasal spray
- 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
- 1 siteUnited Kingdom
- Study dates
- May 2004to Nov 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female
- 18-75 years of age
- bilateral nasal polyposis Grade 2 and above
- with or without asthma
- with or without atopy or aspirin sensitivity
- written informed consent
Who cannot join
- unilateral nasal polyposis
- polypoid lesion suspicious of inverted papilloma, malignancy, Wegeners granulomatosis, sarcoidosis
- known or suspected hypersensitivity to fluticasone propionate or any other constituents of the Investigational Medicinal product (IMP).
- Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
- significant (≥50%)septal deviation
- inability to comply with the requirements of the protocol
- females who are pregnant, lactating or planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ninewells Hospital and Medical School
Dundee, Angus, DD1 9SY
About this study
Official title: A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis
This is the first randomized parallel group clinical trial looking at oral prednisolone induced medical nasal polypectomy followed by maintenance on topical steroid therapy in patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and the factors linking nasal polyps with asthma. We have also taken baseline measurements of a variety of blood, surface and biopsy markers to assess for potential to predict steroid response. Finally, the still unchartered link between nasal polyps and asthma will be explored by measuring Staphylococcal superantigens in serum before and after treatment.
- Conditions
- Nasal Polyps
- Being tested
- Prednisolone, Placebo, fluticasone nasal drops, fluticasone nasal spray
- Keywords
- chronic rhinosinusitis, nasal polyps, oral steroid, intranasal steroid, medical polypectomy
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
tablets 25 mg/day
PlaceboDrug
tablets once daily
fluticasone nasal dropsOther
fluticasone nasal drops 800mcg/d
fluticasone nasal sprayOther
fluticasone nasal spray 400 mcg/d
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablets for 2 weeks followed by fluticasone nasal drops 800mcg/d for 2 months followed by fluticasone nasal spray 400 mcg/d for 4 months Receives: Drug: Placebo; Other: fluticasone nasal drops; Other: fluticasone nasal spray |
| Prednisolone | Experimental | 25 mg Prednisolone OD for 2 weeks followed by Fluticasone nasal drops 800 mcg/d for 2 months, followed by fluticasone nasal spray 400mcg/day for 4 months Receives: Drug: Prednisolone; Other: fluticasone nasal drops; Other: fluticasone nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy Polyp Grading
Measured: 0, 2 weeks, 10 weeks, 28 weeks
Secondary outcomes (7)
Mini RQLQ
Measured: 0, 2 wks, 10 wks, 28 wks
TNS-4
Measured: 0, 2 wks, 10 wks, 28 wks
PNIF
Measured: 0,2 wks, 10 wks,28 wks
Anosmia score
Measured: 0, 2 wks, 10 wks, 28 wks
Scratch n Sniff cards
Measured: 0, 2 wks, 10 wks, 28 wks
OUCC
Measured: 0, 2 wks, 10 wks, 28 wks
1 mcg Synacthen test
Measured: 0, 2 wks, 10 wks, 28 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startMay 2004
- Primary completionFeb 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal PolypsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, NHS Tayside
- Investigators
- Sriram Vaidyanathan, MRCS, Principal investigator, University of DundeeBrian J Lipworth, MD, Study director, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788749
- Sponsor's protocol ID
- GRAY07
- Status last verified
- Nov 2008
- First submitted
- 7 Nov 2008
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Williamson PA, Vaidyanathan S, Clearie K, Barnes M, Lipworth BJ. Airway dysfunction in nasal polyposis: a spectrum of asthmatic disease? Clin Exp Allergy. 2011 Oct;41(10):1379-85. doi: 10.1111/j.1365-2222.2011.03793.x. Epub 2011 Jun 16.
PubMed 21676042Vaidyanathan S, Barnes M, Williamson P, Hopkinson P, Donnan PT, Lipworth B. Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial. Ann Intern Med. 2011 Mar 1;154(5):293-302. doi: 10.7326/0003-4819-154-5-201103010-00003.
PubMed 21357906
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis
- ClinicalTrials.gov ID
- NCT00788749
- Acronym / sponsor ID
- GRAY07
- Conditions
- Nasal Polyps
- Keywords
- chronic rhinosinusitis, nasal polyps, oral steroid, intranasal steroid, medical polypectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, NHS Tayside
- Study start
- May 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 11 Nov 2008 (estimated)
- 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.
This is the first randomized parallel group clinical trial looking at oral prednisolone induced medical nasal polypectomy followed by maintenance on topical steroid therapy in patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and the factors linking nasal polyps with asthma. We have also taken baseline measurements of a variety of blood, surface and biopsy markers to assess for potential to predict steroid response. Finally, the still unchartered link between nasal polyps and asthma will be explored by measuring Staphylococcal superantigens in serum before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Other: fluticasone nasal drops, Other: fluticasone nasal sprayPlacebo tablets for 2 weeks followed by fluticasone nasal drops 800mcg/d for 2 months followed by fluticasone nasal spray 400 mcg/d for 4 months |
| Prednisolone | Experimental | Drug: Prednisolone, Other: fluticasone nasal drops, Other: fluticasone nasal spray25 mg Prednisolone OD for 2 weeks followed by Fluticasone nasal drops 800 mcg/d for 2 months, followed by fluticasone nasal spray 400mcg/day for 4 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female
- 18-75 years of age
- bilateral nasal polyposis Grade 2 and above
- with or without asthma
- with or without atopy or aspirin sensitivity
Key exclusion criteria (7 listed)
- unilateral nasal polyposis
- polypoid lesion suspicious of inverted papilloma, malignancy, Wegeners granulomatosis, sarcoidosis
- known or suspected hypersensitivity to fluticasone propionate or any other constituents of the Investigational Medicinal product (IMP).
- Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
- significant (≥50%)septal deviation
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 |
|---|---|---|
| Prednisolonetablets 25 mg/day | Drug | Prednisolone |
| Placebotablets once daily | Drug | Placebo |
| fluticasone nasal dropsfluticasone nasal drops 800mcg/d | Other | Placebo, Prednisolone |
| fluticasone nasal sprayfluticasone nasal spray 400 mcg/d | Other | Placebo, Prednisolone |
Primary outcome
Endoscopy Polyp Grading
Time frame: 0, 2 weeks, 10 weeks, 28 weeks
7 secondary outcomes
Mini RQLQ
Time frame: 0, 2 wks, 10 wks, 28 wks
TNS-4
Time frame: 0, 2 wks, 10 wks, 28 wks
PNIF
Time frame: 0,2 wks, 10 wks,28 wks
Anosmia score
Time frame: 0, 2 wks, 10 wks, 28 wks
Scratch n Sniff cards
Time frame: 0, 2 wks, 10 wks, 28 wks
OUCC
Time frame: 0, 2 wks, 10 wks, 28 wks
1 mcg Synacthen test
Time frame: 0, 2 wks, 10 wks, 28 wks
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 11 Nov 2008.
- Derived from this study: PubMed 21676042Williamson PA, Vaidyanathan S, Clearie K, Barnes M, Lipworth BJ. Airway dysfunction in nasal polyposis: a spectrum of asthmatic disease? Clin Exp Allergy. 2011 Oct;41(10):1379-85. doi: 10.1111/j.1365-2222.2011.03793.x. Epub 2011 Jun 16.
- Derived from this study: PubMed 21357906Vaidyanathan S, Barnes M, Williamson P, Hopkinson P, Donnan PT, Lipworth B. Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial. Ann Intern Med. 2011 Mar 1;154(5):293-302. doi: 10.7326/0003-4819-154-5-201103010-00003.
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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.
Sriram Vaidyanathan, MRCS principal investigator
University of Dundee
Brian J Lipworth, MD study director
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone, fluticasone nasal drops and fluticasone nasal spray in people with Nasal Polyps, run by University of Dundee at 1 site in United Kingdom.
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 6 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 11 Nov 2008. 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 United Kingdom. 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. 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?
Endoscopy Polyp Grading (time frame: 0, 2 weeks, 10 weeks, 28 weeks). 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 NCT00788749, which also lists 2 linked publications.
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 11 Nov 2008.