NCT02882555

Brief Summary

The hypothesis is that the cough reflex induced by capsaicin is inhibited during exercise. The purpose of this study is to determine if a short muscular exercise inhibits the cough reflex induced by capsaicin inhalation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

August 19, 2016

Last Update Submit

August 24, 2016

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

  • Number of cough efforts occurring within 15 sec of the C5 aerosol at baseline and during exercise

    Video-taped and identified from its sound by 2 observers

    day 0

Study Arms (2)

Children

EXPERIMENTAL

12 concentrations of caspaicin are administered: - 0.6, 1.2, 2.4, 4.8, 9.8, 19.5, 39, 78.1, 156.2, 312.5, 625, 1250 μmol/l. Capsaicin concentration eliciting at least 2 coughs (C2) or 5 coughs (C5) is determined. At least 1-hour-interval from capsaicin dose titration (in order to minimize tachyphylaxy) Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls (normal saline) in random order at baseline At least 1-hour-interval (in order to minimize tachyphylaxy) Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls in random order during exercise, when heart rate is maximum

Behavioral: ExerciseDrug: CapsaicinDrug: Normal saline

Adults

ACTIVE COMPARATOR

As reference for more precise assessment of effects of development. 12 concentrations of caspaicin are administered: 0.49, 0.98, 1.95, 3.9, 7.8, 15.6, 31.3, 62.5, 125, 250, 500, 1000 μmol/l. Capsaicin concentration eliciting at least 2 coughs (C2) or 5 coughs (C5) is determined. At least 1-hour-interval from capsaicin dose titration (in order to minimize tachyphylaxy) Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls (normal saline) in random order at baseline At least 1-hour-interval (in order to minimize tachyphylaxy) Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls in random order during exercise, when heart rate is maximum

Behavioral: ExerciseDrug: CapsaicinDrug: Normal saline

Interventions

ExerciseBEHAVIORAL

6 min running on a motor-driven tredmill in a climate room (18-20°C, humidity \<10 mg/l). Tredmill speed and slope are adjusted to increase heart rate to about 80 % of maximum value predicted for age (= 210 - age in years) during the first 2-3 min and pursued until the end of exercise (3-4 min). Heart rate is measured during the whole exercise.

AdultsChildren
CapsaicinDRUG

A compressed air-driven nebuliser is controlled by a dosimeter and a valve is used to deliver similar inspiratory flows for 400 msec in children and 1200 msec in adults.

AdultsChildren
Normal salineDRUG

A compressed air-driven nebuliser is controlled by a dosimeter and a valve is used to deliver similar inspiratory flows for 400 msec in children and 1200 msec in adults.

AdultsChildren

Eligibility Criteria

Age7 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Obtaining of informed consent (or informed consent of parents or persons with parental authority)
  • Affiliation to social security
  • Negative answer to all 12 questions of medical questionnaire for child or to all 11 questions of medical questionnaire for adult
  • Normal cardio-respiratory examination
  • Normal electrocardiogram
  • Without spirometry obstructive syndrome (FEV1 \> 70% of predicted value and FEV1/FVC \>70%)

You may not qualify if:

  • Refusal or impossibility of obtaining informed consent of person or of persons with parental authority)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cough

Interventions

ExerciseCapsaicinSaline Solution

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPolyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • François MARCHAL, Pr

    Explorations fonctionnelles pédiatriques, Hôpital d'enfants, CHRU de Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 30, 2016

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share