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NCT02624362 Clinical Trial

The Effect of Odors on Asthma Symptoms

Asthma Clinical Trial

Official title:
The Effect of Suggestion of Harmful/Beneficial Effects of Odors on Asthma Symptoms

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02624362
Other study ID # S57940
Secondary ID
Status Enrolling by invitation
Phase N/A
First received December 1, 2015
Last updated October 24, 2017
Start date August 2015
Est. completion date December 2019

Study information
Verified date May 2017
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 48
Est. completion date December 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- A physician diagnosis of asthma

Exclusion Criteria:

- FEV1 lower than 60% predicted

- clinical condition other than asthma

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Therapeutic Suggestion
suggestions about potential beneficial effects of the odor are given
• Asthmogenic Suggestion
suggestions about potential negative effects of the odor are given
Other:
• Phenylethyl Alcohol odor
Over the course of 15 minutes, participants, receive 15 short sniffs of Phenylethyl Alcohol odor

Locations
Country Name City State
Belgium UZ Leuven Leuven

Sponsors (3)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven Katholieke Universiteit Leuven, Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 asthma symptoms measured using the Asthma Symptom Checklist baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Secondary Forced Expiratory Volume at one second (FEV1) Measured using Jaeger Masterscreen Spirometer, according to ERS-ATS guidelines baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Secondary Worry measured using worry Visual Analog Scales baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Secondary Cortisol cortisol awakening response (AUC), and changes in cortisol (AUC) will be measured using saliva sampling baseline, immediately after odor induction, 2 hours after odor induction, at awakening, 30 min after awakening, 24 hours after odor induction
Secondary Change in Heart rate and Heart Rate Variability (HRV) 24 hour heart rate data will be recorded using an ambulatory ECG monitor, and analyzed in 1 hour epochs, extracting mean of successive differences (MSD) as a variable of interest. change from baseline to 24 hours after odor induction
Secondary Change in Respiratory rate respiratory rate (breaths/min) is recorded continuously, and changes between baseline and odor presentation periods will be analysed change from baseline to 15 min odor presentation
Secondary change in Fraction of end-tidal carbon dioxide (FetCO2) FetCO2 (plateau %CO2 in exhaled air) is recorded continuously, and changes between baseline and odor presentation periods will be analysed change from baseline to 15 min odor presentation
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