Back to resultsThe Effect of Odors on Asthma Symptoms
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Therapeutic Suggestion
Asthmogenic Suggestion
Phenylethyl Alcohol odor
Sponsored by
About this trial
This is an interventional basic science trial for Asthma focused on measuring Odor, trigger, inflammation, nocebo
Eligibility Criteria
Inclusion Criteria:
- A physician diagnosis of asthma
Exclusion Criteria:
- FEV1 lower than 60% predicted
- clinical condition other than asthma
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Odor+ Positive belief
Odor + Negative belief
Arm Description
Participants receive 15 minute odor presentation (Phenylethyl Alcohol odor) accompanied by the suggestion that this odor improves asthma symptoms (therapeutic suggestion)
Participants receive 15 minute odor presentation (Phenylethyl Alcohol odor) accompanied by the suggestion that this odor worsens asthma symptoms (asthmogenic suggestion)
Outcomes
Primary Outcome Measures
Change from Baseline Exhaled Nitric Oxide to 24 hours after odor induction
Fraction of exhaled nitric oxide
Secondary Outcome Measures
asthma symptoms
measured using the Asthma Symptom Checklist
Forced Expiratory Volume at one second (FEV1)
Measured using Jaeger Masterscreen Spirometer, according to ERS-ATS guidelines
Worry
measured using worry Visual Analog Scales
Cortisol
cortisol awakening response (AUC), and changes in cortisol (AUC) will be measured using saliva sampling
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 in Respiratory rate
respiratory rate (breaths/min) is recorded continuously, and changes between baseline and odor presentation periods will be analysed
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
Full Information
NCT ID
NCT02624362
First Posted
December 1, 2015
Last Updated
October 24, 2017
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, Research Foundation Flanders
1. Study Identification
Unique Protocol Identification Number
NCT02624362
Brief Title
The Effect of Odors on Asthma Symptoms
Official Title
The Effect of Suggestion of Harmful/Beneficial Effects of Odors on Asthma Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, Research Foundation Flanders
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Odor, trigger, inflammation, nocebo
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Odor+ Positive belief
Arm Type
Experimental
Arm Description
Participants receive 15 minute odor presentation (Phenylethyl Alcohol odor) accompanied by the suggestion that this odor improves asthma symptoms (therapeutic suggestion)
Arm Title
Odor + Negative belief
Arm Type
Experimental
Arm Description
Participants receive 15 minute odor presentation (Phenylethyl Alcohol odor) accompanied by the suggestion that this odor worsens asthma symptoms (asthmogenic suggestion)
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Suggestion
Other Intervention Name(s)
placebo suggestion, positive treatment belief induction
Intervention Description
suggestions about potential beneficial effects of the odor are given
Intervention Type
Behavioral
Intervention Name(s)
Asthmogenic Suggestion
Other Intervention Name(s)
nocebo suggestion, negative treatment belief
Intervention Description
suggestions about potential negative effects of the odor are given
Intervention Type
Other
Intervention Name(s)
Phenylethyl Alcohol odor
Intervention Description
Over the course of 15 minutes, participants, receive 15 short sniffs of Phenylethyl Alcohol odor
Primary Outcome Measure Information:
Title
Change from Baseline Exhaled Nitric Oxide to 24 hours after odor induction
Description
Fraction of exhaled nitric oxide
Time Frame
baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Secondary Outcome Measure Information:
Title
asthma symptoms
Description
measured using the Asthma Symptom Checklist
Time Frame
baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Title
Forced Expiratory Volume at one second (FEV1)
Description
Measured using Jaeger Masterscreen Spirometer, according to ERS-ATS guidelines
Time Frame
baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Title
Worry
Description
measured using worry Visual Analog Scales
Time Frame
baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Title
Cortisol
Description
cortisol awakening response (AUC), and changes in cortisol (AUC) will be measured using saliva sampling
Time Frame
baseline, immediately after odor induction, 2 hours after odor induction, at awakening, 30 min after awakening, 24 hours after odor induction
Title
Change in Heart rate and Heart Rate Variability (HRV)
Description
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.
Time Frame
change from baseline to 24 hours after odor induction
Title
Change in Respiratory rate
Description
respiratory rate (breaths/min) is recorded continuously, and changes between baseline and odor presentation periods will be analysed
Time Frame
change from baseline to 15 min odor presentation
Title
change in Fraction of end-tidal carbon dioxide (FetCO2)
Description
FetCO2 (plateau %CO2 in exhaled air) is recorded continuously, and changes between baseline and odor presentation periods will be analysed
Time Frame
change from baseline to 15 min odor presentation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A physician diagnosis of asthma
Exclusion Criteria:
FEV1 lower than 60% predicted
clinical condition other than asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Janssens, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
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The Effect of Odors on Asthma Symptoms
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