NCT01562093

Brief Summary

In this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

4.4 years

First QC Date

March 21, 2012

Last Update Submit

August 30, 2016

Conditions

Asthma

Keywords

Adrenal Cortex HormonesSpirometryAdministration, IntranasalNasal blockageNasal sprays

Outcome Measures

Primary Outcomes (1)

  • forced expiratory volume

    spirometry, methacholine and mannitol

    up to 12 weeks

Secondary Outcomes (4)

  • improvement in nasal blockage

    up to 12 weeks

  • nasal and exhaled NO

    up to 12 weeks

  • wheeze

    up to 12 weeks

  • subjective improvement in asthma symptomatology

    up to 12 weeks

Study Arms (2)

local nasal steroids

EXPERIMENTAL
Drug: corticosteroid nasal spray

placebo

PLACEBO COMPARATOR
Drug: placebo nasal spray

Interventions

corticosteroid nasal sprayDRUG

fluticasone furoate 55 µg (formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water) once daily in each nostril for 3 months

Also known as: Avamys
local nasal steroids
placebo nasal sprayDRUG

formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months

placebo

Eligibility Criteria

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

You may qualify if:

  • asthma (according to British Thoracic Society guideline)
  • \>18 years

You may not qualify if:

  • pregnancy
  • systemic disease with nasal manifestations
  • cancer of the nose
  • currently receiving cancer therapy
  • previous nose surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olav University Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

AsthmaNasal Obstruction

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesNose DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Sverre Steinsvåg, MD prof

    St. Olav University Hospital, Trondheim, Norway

    STUDY DIRECTOR

  • Malcolm Sue-Chu, MD

    St Olavs University Hospital Trondheim

    PRINCIPAL INVESTIGATOR

  • Vegard Bugten, MD

    St Olavs University Hospital Trondheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

NO(1)