NCT00788463

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2009

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2011

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

2.4 years

First QC Date

November 7, 2008

Last Update Submit

August 25, 2017

Conditions

Nasal Polyps

Keywords

administration, intranasalaerosolbeclomethasoneQVARcorticosteroidsnasal polypsrhinomanometryRhinitis Quality of Life QuestionnaireQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire

    0, 1, 3, 6 months

Secondary Outcomes (1)

  • Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry

    0, 1, 3, 6 months

Study Arms (2)

Aerosol

EXPERIMENTAL
Drug: Intranasal Beclomethasone aerosol

Spray

ACTIVE COMPARATOR
Drug: Intranasal Beclomethasone spray

Interventions

Intranasal Beclomethasone aerosolDRUG

Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.

Also known as: QVAR
Aerosol
Intranasal Beclomethasone sprayDRUG

Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.

Spray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • New diagnosis of nasal polyps confirmed by two physicians

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergy Clinic, London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Related Publications (17)

  • 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.

    PMID: 13196789BACKGROUND

  • SMITH 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.

    PMID: 14308145BACKGROUND

  • Taub 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.

    PMID: 4891434BACKGROUND

  • Norman 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.

    PMID: 5230040BACKGROUND

  • Mygind 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.

    PMID: 4800886BACKGROUND

  • Mygind 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.

    PMID: 1095246BACKGROUND

  • Sorensen 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.

    PMID: 790892BACKGROUND

  • Pedersen 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.

    PMID: 790891BACKGROUND

  • Mygind 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.

    PMID: 665215BACKGROUND

  • Toft 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.

    PMID: 7116616BACKGROUND

  • Krouse HA, Phung ND, Klaustermeyer WB. Intranasal beclomethasone in severe rhinosinusitis and nasal polyps. Ann Allergy. 1983 Jun;50(6):385-8.

    PMID: 6344703BACKGROUND

  • el 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.

    PMID: 7499945BACKGROUND

  • Irifune 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.

    PMID: 10077256BACKGROUND

  • Vidgren 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.

    PMID: 10837586BACKGROUND

  • Dunn 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.

    PMID: 6379630BACKGROUND

  • Sidwell S. A comparison of the efficacy and tolerance of an aqueous beclomethasone dipropionate nasal spray with the conventional pressurized spray. Curr Med Res Opin. 1983;8(9):659-64. doi: 10.1185/03007998309109815.

    PMID: 6667629BACKGROUND

  • Harries MG, Anderson PB, Gibson GJ, Hof ZE, Baggott PJ. A comparison of an aqueous and a pressurized nasal spray of beclomethasone dipropionate in the management of seasonal rhinitis. Pharmatherapeutica. 1984;3(9):623-5.

    PMID: 6374683BACKGROUND

MeSH Terms

Conditions

Nasal Polyps

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Jorge A Mazza, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 11, 2008

Study Start

November 23, 2006

Primary Completion

March 30, 2009

Study Completion

November 30, 2011

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

CA(1)