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Trial record 2 of 150 for:    Ipratropium OR atrovent

Atrovent in Exercise Induced Laryngeal Obstruction (EILO)

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ClinicalTrials.gov Identifier: NCT02755714
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
Exercise Induced Laryngeal Obstruction (EILO) is a condition not uncommon in otherwise healthy young people. EILO is caused by posteromedial collapse of supraglottic structures or medialization of the vocal folds, or both, during high intensity exercise. There are currently no treatments available that is properly evidence based. However, case reports suggest a possible effect from the "asthma drug" Ipratropium Bromide (Atrovent®). The current project is an open label pilot study, aiming to test if Atrovent can influence the occurence of EILO, either postponing the onset during exercise or fully prevent the condition to occur.

Condition or disease Intervention/treatment Phase
Exercise Induced Laryngeal Obstruction (EILO) Drug: Ipratropium bromide spray Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ipratropium Bromide (Atrovent®) Used to Treat Exercise Induced Laryngeal Obstruction (EILO). An Open Label Pilot Study
Actual Study Start Date : June 22, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No Atrovent ®
NO INTERVENTION: The patient will not receive Ipratropium bromide spray (MDI) 20 μg ,(Atrovent ®) prior to CLE testing
Experimental: Atrovent ®
INTERVENTION: Ipratropium bromide spray (MDI) 20 μg (Atrovent ®) prior to CLE testing
Drug: Ipratropium bromide spray
The patient will - or will not - receive Ipratropium bromide spray (MDI) 20 μg given through a plastic spacer two puffs 1 hour before a continuous laryngoscopy exercise test (CLE-test)
Other Name: Atrovent




Primary Outcome Measures :
  1. CLE test-scores (please se above; Detailed Study Description) [ Time Frame: At exhaustion when the test stops, approximately 10-15 minutes after test commencement ]
    CLE test-scores will be rated from videos obtained during the CLE test


Secondary Outcome Measures :
  1. Patient perceived breathing difficulties during the CLE test [ Time Frame: At exhaustion when the test stops, approximately 10-15 minutes after test commencement ]
    At exhaustion when the test stops, approximately 10-15 minutes after commencement

  2. Investigator scored breathing difficulties during the CLE test [ Time Frame: At exhaustion when the test stops, approximately 10-15 minutes after test commencement ]


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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: Exercise Induced Inspiratory Symptoms and a CLE score Equal to or larger than three Exclusion Criteria: Participants should be free from co-morbidities other than stable and weel treated asthma. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755714


Contacts
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Contact: THOMAS HALVORSEN, MD and PhD +47 9246 4843 thomas.halvorsen@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Thomas Halvorsen, MD and PhD    +47 9246 4843    thomas.halvorsen@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Study Director: SKADBERG BRITT, MD and PhD HAUKELAND UNIVERSITY HOSPITAL, PEDIATRIC DEPARTMENT

Publications:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02755714     History of Changes
Other Study ID Numbers: 2014/1885
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Ipratropium
Bromides
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action