NCT04189016

Brief Summary

Investigating nasal muco-ciliary clearance by scintigraphy

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
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

November 28, 2019

Last Update Submit

January 13, 2021

Conditions

Obstructive Airway Diseases

Outcome Measures

Primary Outcomes (2)

  • Nasal Mucociliary Clearance

    Change in nasal mucociliary clearance velocity (mm/min) from placebo to salt inhalation

    At study day 1 and 2

  • Nasal Mucociliary Clearance

    Change in nasal mucociliary clearance retention (%) from placebo to salt inhalation

    At study day 1 and 2

Secondary Outcomes (2)

  • Spirometry

    At the beginning and the end of study day 1 and 2

  • Saccharin test

    At study day 1 and 2

Study Arms (2)

Salt particle inhaler with content

ACTIVE COMPARATOR

Participants inhaling from a salt particle inhaler with content

Device: Inhalation from a salt particle inhaler with or without content

Salt particle inhaler without content

PLACEBO COMPARATOR

Participants inhaling from a salt particle inhaler without content

Device: Inhalation from a salt particle inhaler with or without content

Interventions

Inhalation from a salt particle inhaler with or without contentDEVICE

Inhalation from inhaler with (active) or without (placebo) content

Salt particle inhaler with contentSalt particle inhaler without content

Eligibility Criteria

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

You may qualify if:

  • COPD patients (all severities in chronic, stable condition)
  • Asthma patients (in stable condition without acute asthma symptoms)
  • Healthy subjects, incl. smokers (no chronic nasal, upper or lower respiratory diseases)

You may not qualify if:

  • Age under 18 years
  • Upper respiratory tract infection / cold within the last 3 weeks and at least 3 weeks must pass from the person has become well to the examination
  • Allergic / non-allergic rhinitis (hay fever)
  • Chronic sinusitis
  • Acute respiratory tract infection in antibiotic therapy
  • Applied salt inhalation within the past month
  • Pregnant or breastfeeding women
  • Nuclear medical examination within the past month
  • Cannot taste saccharin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Clin nuclear and physiolog dept.

Copenhagen, 2100, Denmark

Location

Central Study Contacts

Zainab Saraj, Cand.Pharm.

CONTACT

0045 22268865zs@liitacare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 6, 2019

Study Start

February 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)