Nasal PolypsPhase 2NCT00788463
A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps
A Phase 2 study testing Intranasal Beclomethasone aerosol and Intranasal Beclomethasone spray in people with Nasal Polyps, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol or spray is more effective in treatment of nasal polyps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Intranasal Beclomethasone aerosol and Intranasal Beclomethasone spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2006to 30 Nov 2011
- Phase
- Phase 2
- 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
- 18 years old
- New diagnosis of nasal polyps confirmed by two physicians
Who cannot join
- Intranasal corticosteroid use within 4 weeks
- Oral corticosteroids use within 4 weeks
- Oral corticosteroid inhalation (ie for treatment of asthma or COPD) of Budesonide >400ug daily, Fluticasone >250ug daily, Beclomethasone >400ug daily
- Contraindication to intranasal corticosteroid
- Inability to give informed consent
- Participation in another clinical trial
- Pregnancy (or not using effective method of contraception) or lactation
- Cystic fibrosis
Trial locations and contacts
1 site in 1 country.
Canada1 site
Allergy Clinic, London Health Sciences Centre
London, Ontario, N6A 4G5
About this study
The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol or spray is more effective in treatment of nasal polyps.
Read the detailed description
Aqueous and aerosol delivery of intranasal corticosteroids has never been directly compared previously in patients with nasal polyps and it is unknown whether one is superior.
This objective of this study is to compare the efficacy of intranasal beclomethasone by two different delivery systems, aerosol and aqueous spray in patients with nasal polyps. Primary endpoint is the difference in the overall quality of life as measured by the Rhinitis Quality of Life Questionnaire. The secondary endpoint is the change in Nasal Airflow Resistance as measured by rhinomanometry.
- Conditions
- Nasal Polyps
- Being tested
- Intranasal Beclomethasone aerosol, Intranasal Beclomethasone spray
- Keywords
- administration, intranasal, aerosol, beclomethasone, QVAR, corticosteroids, nasal polyps, rhinomanometry, Rhinitis Quality of Life Questionnaire, Quality of Life
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Beclomethasone aerosolDrug
Also called QVAR
Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.
Intranasal Beclomethasone sprayDrug
Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Aerosol | Experimental | Not described Receives: Drug: Intranasal Beclomethasone aerosol |
| Spray | Active comparator | Not described Receives: Drug: Intranasal Beclomethasone spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire
Measured: 0, 1, 3, 6 months
Secondary outcomes (1)
Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry
Measured: 0, 1, 3, 6 months
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 start23 Nov 2006
- Primary completion30 Mar 2009
- Study completion30 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge A Mazza, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788463
- Sponsor's protocol ID
- R-06-542
- Status last verified
- Aug 2017
- First submitted
- 7 Nov 2008
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
SILCOX LE. The intranasal use of hydrocortisone alcohol. AMA Arch Otolaryngol. 1954 Oct;60(4):431-9. doi: 10.1001/archotol.1954.00720010443005. No abstract available.
PubMed 13196789SMITH RE. DEXAMETHASONE NASAL AEROSOL IN NASAL POLYPS AND HYPERTROPHIC ALLERGIC RHINITIS: A CLINICAL AND CONTROLLED EVALUATION. Ann Allergy. 1965 Jun;23:273-6. No abstract available.
PubMed 14308145Taub SJ. Dexamethasone nasal aerosol vs. placebo in the treatment of nasal polyposis. Eye Ear Nose Throat Mon. 1968 Aug;47(8):392-5. No abstract available.
PubMed 4891434Norman PS, Winkenwerder WL, Agbayani BF, Migeon CJ. Adrenal function during the use of dexamethasone aerosols in the treatment of ragweed hay fever. J Allergy. 1967 Jul;40(1):57-61. doi: 10.1016/0021-8707(67)90060-3. No abstract available.
PubMed 5230040Mygind N, Hansen I. Beclomethasone dipropionate aerosol effect on the adrenals in normal persons. Acta Allergol. 1973 Sep;28(3):211-8. doi: 10.1111/j.1398-9995.1973.tb01327.x. No abstract available.
PubMed 4800886Mygind N, Pedersen CB, Prytz S, Sorensen H. Treatment of nasal polyps with intranasal beclomethasone dipropionate aerosol. Clin Allergy. 1975 Jun;5(2):159-64. doi: 10.1111/j.1365-2222.1975.tb01848.x.
PubMed 1095246Sorensen H, Mygind N, Pedersen CB, Prytz S. Long-term treatment of nasal polyps with beclomethasone dipropionate aerosol. III. Morphological studies and conclusions. Acta Otolaryngol. 1976 Sep-Oct;82(3-4):260-2. doi: 10.3109/00016487609120899.
PubMed 790892Pedersen CB, Mygind N, Sorensen H, Prytz S. Long-term treatment of nasal polyps with beclomethasone dipropionate aerosol. II. Clinical results. Acta Otolaryngol. 1976 Sep-Oct;82(3-4):256-9. doi: 10.3109/00016487609120898.
PubMed 790891Mygind N, Sorensen H, Pedersen CB. The nasal mucosa during long-term treatment with beclomethasone dipropionate aerosol. A light-and scanning electron microscopic study of nasal polyps. Acta Otolaryngol. 1978 May-Jun;85(5-6):437-43.
PubMed 665215Toft A, Wihl JA, Toxman J, Mygind N. Double-blind comparison between beclomethasone dipropionate as aerosol and as powder in patients with nasal polyposis. Clin Allergy. 1982 Jul;12(4):391-401. doi: 10.1111/j.1365-2222.1982.tb02544.x.
PubMed 7116616Krouse HA, Phung ND, Klaustermeyer WB. Intranasal beclomethasone in severe rhinosinusitis and nasal polyps. Ann Allergy. 1983 Jun;50(6):385-8.
PubMed 6344703el Naggar M, Kale S, Aldren C, Martin F. Effect of Beconase nasal spray on olfactory function in post-nasal polypectomy patients: a prospective controlled trial. J Laryngol Otol. 1995 Oct;109(10):941-4. doi: 10.1017/s002221510013172x.
PubMed 7499945Irifune M, Ogino S, Harada T, Abe Y. Topical treatment of nasal polyps with a beclomethasone dipropionate powder preparation. Auris Nasus Larynx. 1999 Jan;26(1):49-55. doi: 10.1016/s0385-8146(98)00062-5.
PubMed 10077256Vidgren MT, Kublik H. Nasal delivery systems and their effect on deposition and absorption. Adv Drug Deliv Rev. 1998 Jan 5;29(1-2):157-177. doi: 10.1016/s0169-409x(97)00067-7.
PubMed 10837586Dunn AM, Wilson RS, Baggott PJ. A comparison of beclomethasone dipropionate aqueous nasal spray and beclomethasone dipropionate pressurized nasal spray in the management of seasonal rhinitis. Postgrad Med J. 1984 Jun;60(704):404-6. doi: 10.1136/pgmj.60.704.404.
PubMed 6379630
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps
- ClinicalTrials.gov ID
- NCT00788463
- Acronym / sponsor ID
- R-06-542
- Conditions
- Nasal Polyps
- Keywords
- administration, intranasal, aerosol, beclomethasone, QVAR, corticosteroids, nasal polyps, rhinomanometry, Rhinitis Quality of Life Questionnaire
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 23 Nov 2006 (actual)
- Primary completion
- 30 Mar 2009 (actual)
- Study completion
- 30 Nov 2011 (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.
The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol or spray is more effective in treatment of nasal polyps.
Detailed description
Aqueous and aerosol delivery of intranasal corticosteroids has never been directly compared previously in patients with nasal polyps and it is unknown whether one is superior.
This objective of this study is to compare the efficacy of intranasal beclomethasone by two different delivery systems, aerosol and aqueous spray in patients with nasal polyps. Primary endpoint is the difference in the overall quality of life as measured by the Rhinitis Quality of Life Questionnaire. The secondary endpoint is the change in Nasal Airflow Resistance as measured by rhinomanometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerosol | Experimental | Drug: Intranasal Beclomethasone aerosol |
| Spray | Active comparator | Drug: Intranasal Beclomethasone spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old
- New diagnosis of nasal polyps confirmed by two physicians
Key exclusion criteria (8 listed)
- Intranasal corticosteroid use within 4 weeks
- Oral corticosteroids use within 4 weeks
- Oral corticosteroid inhalation (ie for treatment of asthma or COPD) of Budesonide >400ug daily, Fluticasone >250ug daily, Beclomethasone >400ug daily
- Contraindication to intranasal corticosteroid
- Inability to give informed consent
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 |
|---|---|---|
| Intranasal Beclomethasone aerosolAlso: QVARBeclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months. | Drug | Aerosol |
| Intranasal Beclomethasone sprayBeclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months. | Drug | Spray |
Primary outcome
Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire
Time frame: 0, 1, 3, 6 months
1 secondary outcome
Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry
Time frame: 0, 1, 3, 6 months
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 28 Aug 2017.
- Background: PubMed 13196789SILCOX LE. The intranasal use of hydrocortisone alcohol. AMA Arch Otolaryngol. 1954 Oct;60(4):431-9. doi: 10.1001/archotol.1954.00720010443005. No abstract available.
- Background: PubMed 14308145SMITH RE. DEXAMETHASONE NASAL AEROSOL IN NASAL POLYPS AND HYPERTROPHIC ALLERGIC RHINITIS: A CLINICAL AND CONTROLLED EVALUATION. Ann Allergy. 1965 Jun;23:273-6. No abstract available.
- Background: PubMed 4891434Taub SJ. Dexamethasone nasal aerosol vs. placebo in the treatment of nasal polyposis. Eye Ear Nose Throat Mon. 1968 Aug;47(8):392-5. No abstract available.
- Background: PubMed 5230040Norman PS, Winkenwerder WL, Agbayani BF, Migeon CJ. Adrenal function during the use of dexamethasone aerosols in the treatment of ragweed hay fever. J Allergy. 1967 Jul;40(1):57-61. doi: 10.1016/0021-8707(67)90060-3. No abstract available.
- Background: PubMed 4800886Mygind N, Hansen I. Beclomethasone dipropionate aerosol effect on the adrenals in normal persons. Acta Allergol. 1973 Sep;28(3):211-8. doi: 10.1111/j.1398-9995.1973.tb01327.x. No abstract available.
- Background: PubMed 1095246Mygind N, Pedersen CB, Prytz S, Sorensen H. Treatment of nasal polyps with intranasal beclomethasone dipropionate aerosol. Clin Allergy. 1975 Jun;5(2):159-64. doi: 10.1111/j.1365-2222.1975.tb01848.x.
- Background: PubMed 790892Sorensen H, Mygind N, Pedersen CB, Prytz S. Long-term treatment of nasal polyps with beclomethasone dipropionate aerosol. III. Morphological studies and conclusions. Acta Otolaryngol. 1976 Sep-Oct;82(3-4):260-2. doi: 10.3109/00016487609120899.
- Background: PubMed 790891Pedersen CB, Mygind N, Sorensen H, Prytz S. Long-term treatment of nasal polyps with beclomethasone dipropionate aerosol. II. Clinical results. Acta Otolaryngol. 1976 Sep-Oct;82(3-4):256-9. doi: 10.3109/00016487609120898.
- Background: PubMed 665215Mygind N, Sorensen H, Pedersen CB. The nasal mucosa during long-term treatment with beclomethasone dipropionate aerosol. A light-and scanning electron microscopic study of nasal polyps. Acta Otolaryngol. 1978 May-Jun;85(5-6):437-43.
- Background: PubMed 7116616Toft A, Wihl JA, Toxman J, Mygind N. Double-blind comparison between beclomethasone dipropionate as aerosol and as powder in patients with nasal polyposis. Clin Allergy. 1982 Jul;12(4):391-401. doi: 10.1111/j.1365-2222.1982.tb02544.x.
- Background: PubMed 6344703Krouse HA, Phung ND, Klaustermeyer WB. Intranasal beclomethasone in severe rhinosinusitis and nasal polyps. Ann Allergy. 1983 Jun;50(6):385-8.
- Background: PubMed 7499945el Naggar M, Kale S, Aldren C, Martin F. Effect of Beconase nasal spray on olfactory function in post-nasal polypectomy patients: a prospective controlled trial. J Laryngol Otol. 1995 Oct;109(10):941-4. doi: 10.1017/s002221510013172x.
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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.
Jorge A Mazza, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Beclomethasone aerosol and Intranasal Beclomethasone spray in people with Nasal Polyps, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 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 28 Aug 2017. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire (time frame: 0, 1, 3, 6 months). 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 NCT00788463, which also lists 17 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 28 Aug 2017.