NCT01580137

Brief Summary

The purpose of this study is to find out if we can predict the progress of acute upper respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric oxide measurement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

April 17, 2012

Last Update Submit

October 29, 2013

Conditions

Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis

Keywords

acute respiratory tract infectioncommon coldacute bacterial rhinosinusitisadultconscript

Outcome Measures

Primary Outcomes (1)

  • Bacterial maxillary sinusitis

    Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)

    2 months

Secondary Outcomes (1)

  • Bacterial sinusitis

    2 months

Study Arms (2)

healthy conscripts

non allergic subjects who have not a history of recurrent rhinosinusitis

subjects with recurrent rhinosinusitis

subjects who have experienced recurrent rhinosinusitis episodes (3 during the previous 3 years)

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Finnish conscripts from the prigade of Kainuu who suffer from acute common cold with nasal symptoms. Consecutive sample. Subjects with known allergies, nasal polyps and prior sinus surgery are excluded.

You may qualify if:

  • Conscript with acute upper respiratory tract infection symptoms (nasal obstruction/decongestion, post nasal drip or nasal secretion) lasted for 2-4 days

You may not qualify if:

  • Allergy, asthma, nasal polyposis, sinus surgery, autoimmune illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Defence Force, Centre for Military Medicine

Kajaani, Kainuu, FI 87500, Finland

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Petri Koivunen, Dosent

    Dept of Otolaryngology, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

  • Timo Koskenkorva, MD

    Dept of Otolaryngology, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

  • Mervi Närkiö, MD

    Finnish Defence Force

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 18, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2014

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

FI(1)