NCT02624362

Brief Summary

An extended replication of Jaen \& Dalton (2014), the investigators aim to investigate the role of odors and associated trigger beliefs on symptom perception and airway inflammation in individuals with asthma

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
4mo left

Started Aug 2015

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress97%
Aug 2015Dec 2026

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

10.9 years

First QC Date

December 1, 2015

Last Update Submit

July 2, 2024

Conditions

Asthma

Keywords

Odortriggerinflammationnocebo

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Exhaled Nitric Oxide to 24 hours after odor induction

    Fraction of exhaled nitric oxide

    baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction

Secondary Outcomes (7)

  • asthma symptoms

    baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction

  • Forced Expiratory Volume at one second (FEV1)

    baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction

  • Worry

    baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction

  • Cortisol

    baseline, immediately after odor induction, 2 hours after odor induction, at awakening, 30 min after awakening, 24 hours after odor induction

  • Change in Heart rate and Heart Rate Variability (HRV)

    change from baseline to 24 hours after odor induction

  • +2 more secondary outcomes

Study Arms (2)

Odor+ Positive belief

EXPERIMENTAL

Participants receive 15 minute odor presentation (Phenylethyl Alcohol odor) accompanied by the suggestion that this odor improves asthma symptoms (therapeutic suggestion)

Behavioral: Therapeutic SuggestionOther: Phenylethyl Alcohol odor

Odor + Negative belief

EXPERIMENTAL

Participants receive 15 minute odor presentation (Phenylethyl Alcohol odor) accompanied by the suggestion that this odor worsens asthma symptoms (asthmogenic suggestion)

Behavioral: Asthmogenic SuggestionOther: Phenylethyl Alcohol odor

Interventions

Therapeutic SuggestionBEHAVIORAL

suggestions about potential beneficial effects of the odor are given

Also known as: placebo suggestion, positive treatment belief induction
Odor+ Positive belief
Asthmogenic SuggestionBEHAVIORAL

suggestions about potential negative effects of the odor are given

Also known as: nocebo suggestion, negative treatment belief
Odor + Negative belief
Phenylethyl Alcohol odorOTHER

Over the course of 15 minutes, participants, receive 15 short sniffs of Phenylethyl Alcohol odor

Odor + Negative beliefOdor+ Positive belief

Eligibility Criteria

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

You may qualify if:

  • A physician diagnosis of asthma

You may not qualify if:

  • FEV1 lower than 60% predicted
  • clinical condition other than asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

AsthmaInflammation

Interventions

SuggestionEthanolOdorants

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesAlcoholsOrganic ChemicalsEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Thomas Janssens, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 8, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(1)