The Effect of Odors on Asthma Symptoms

NCT ID: NCT02624362

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Participants with asthma are randomly assigned to a 15-min (phenylethyl alcohol) odor inhalation, accompanied by either an asthmogenic suggestion (nocebo), or a therapeutic suggestion (placebo). Airway inflammation, lung function, and asthma symptoms are measured in response to the odor/suggestion, up to 24 hours after odor inhalation. The investigators are also measuring worry and heart rate variability as potential mediators of the response.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Odor+ Positive belief

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

Group Type EXPERIMENTAL

Therapeutic Suggestion

Intervention Type BEHAVIORAL

suggestions about potential beneficial effects of the odor are given

Phenylethyl Alcohol odor

Intervention Type OTHER

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

Odor + Negative belief

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

Group Type EXPERIMENTAL

Asthmogenic Suggestion

Intervention Type BEHAVIORAL

suggestions about potential negative effects of the odor are given

Phenylethyl Alcohol odor

Intervention Type OTHER

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

Interventions

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Therapeutic Suggestion

suggestions about potential beneficial effects of the odor are given

Intervention Type BEHAVIORAL

Asthmogenic Suggestion

suggestions about potential negative effects of the odor are given

Intervention Type BEHAVIORAL

Phenylethyl Alcohol odor

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

Intervention Type OTHER

Other Intervention Names

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placebo suggestion positive treatment belief induction nocebo suggestion negative treatment belief

Eligibility Criteria

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Inclusion Criteria

* A physician diagnosis of asthma

Exclusion Criteria

* FEV1 lower than 60% predicted
* clinical condition other than asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Research Foundation Flanders

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Janssens, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S57940

Identifier Type: -

Identifier Source: org_study_id

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