Exercise Challenge in a Cold Chamber

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT02026492
First received: December 19, 2013
Last updated: January 1, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced bronchoconstriction. The sensitivity and repeatability of the exercise test will be measured.


Condition Intervention
Exercise-induced Asthma
Other: Exercise challenge in a cold chamber
Other: Methacholine challenge

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Exercise-induced Bronchoconstriction in a Cold Chamber Compared to Methacholine Challenge

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Agreement of metacholine challenge and the combined exercise/cold-air challenge [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Lung function will be measured prior and after methacholine- and exercise/cold-air challenges. The maximal fall in forced expiratory volume in one second (FEV1, percent predicted) after methacholine and cold air challenge will be compared by statistical correlation. For both methods the sensitivity and the specificity to predict an exercise induced asthma will be calculated by a receiver operating characteristic (ROC analysis).

    All subjects receive Salbutamol to relief them from bronchial constriction at the end of the test.



Secondary Outcome Measures:
  • Repeatability of the combined exercise/cold-air challenge [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The combined exercise/cold-air challenge will be performed twice within one week. Post challenge the FEV1 will be measured after 5, 10, 20, and 30 minutes. The maximal fall in FEV1 (percent predicted) and the area under the curve (AUC) will be compared. The agreement and the repeatability of the maximal fall in FEV1 and of the AUC will be measured by correlation and by the method of Bland and Altman.


Other Outcome Measures:
  • Agreement of the combined exercise/cold-air challenge with the Asthma-score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    All children who participate will fill the asthma control test (ACT) and all adult subjects will fill the asthma control questionnaire (ACQ). The asthma-score will be compared with the severity of the exercise induced asthma measured by the maximal fall in FEV1.


Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
40 patients aged 6-18 years
All 40 patients with a diagnosis of asthma are recruited from the outpatients clinic of the department of Pediatric Pneumology and Allergology of the University Hospital Frankfurt. Patients undergo a methacholine challenge and two exercise challenges in a cold chamber.
Other: Exercise challenge in a cold chamber
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
Other: Methacholine challenge
nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg
40 subjects aged 18-45 years
All subjects show bronchial hyperresponsiveness e.g. dyspnea when exercising in cold environment, in their medical history. Subjects undergo a methacholine challenge and exercise challenge in a cold chamber.
Other: Exercise challenge in a cold chamber
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
Other: Methacholine challenge
nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg

Detailed Description:

Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest. To provoke asthma symptoms a provocation test is necessary, e.g., by bronchial methacholine testing or by a standardised exercise test on a treadmill. The correlation between methacholine and exercise test is fair, possibly because both methods measure different kinds of bronchial hyperresponsiveness. Moreover, the sensitivity and the repeatability of the exercise test is fair.

The value of the methacholine test to predict a positive exercise test will be measured. We hypothesize that the exercise test in a cold chamber, a combination of two provocation methods cold air and exercise, is more sensitive to detect EIB and that the test has a better repeatability.

  Eligibility

Ages Eligible for Study:   6 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Patients: Age >6 and <18 years
  • Subjects: Age >/=18 and <45 years
  • sportive, 1-2x exercise per week
  • bronchial hyperresponsiveness in the medical history

Exclusion Criteria:

  • lung function Forced vital capacity (FVC) <80% and Forced expiratory volume in 1 second (FEV1) <75%
  • chronic diseases or infections (e.g. HIV, Tbc)
  • pregnancy
  • systemic corticosteroid-treatment
  • inhalative corticosteroid therapy or leukotriene antagonists <14d
  • alcohol, substance or drug abuse
  • smokers
  • inability to capture extend and consequences of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026492

Locations
Germany
Goethe University Hospital Frankfurt Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Johannes Schulze, Dr.    +49 69 6301 5381    johannes.schulze@kgu.de   
Contact: Stefan Zielen, Prof. Dr    +49 69 6301 83063    stefan.zielen@kgu.de   
Principal Investigator: Johannes Schulze, PD Dr.         
Sub-Investigator: Stefan Zielen, Prof. Dr.         
Sub-Investigator: Martin Rosewich, Dr.         
Sub-Investigator: Sandra Voß, Dr.         
Sub-Investigator: Natali Lasowski, cand.med.         
Sub-Investigator: Theresa Friedrich, cand.med.         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Study Chair: Johannes Schulze, MD Johann Wolfgang Goethe University Hospitals
  More Information

Publications:
Responsible Party: Johannes Schulze MD, Consultant Pediatric Allergy and Pneumology, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT02026492     History of Changes
Other Study ID Numbers: KGU-208/13
Study First Received: December 19, 2013
Last Updated: January 1, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
exercise-induced bronchoconstriction
exercise-induced asthma
cold chamber
exercise challenge
cold air challenge
combined exercise- and cold-air challenge
methacholine challenge

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methacholine Chloride
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Therapeutic Uses
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014