NCT02026492

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

December 19, 2013

Last Update Submit

March 16, 2015

Conditions

Exercise-induced Asthma

Keywords

exercise-induced bronchoconstrictionexercise-induced asthmacold chamberexercise challengecold air challengecombined exercise- and cold-air challengemethacholine challenge

Outcome Measures

Primary Outcomes (1)

  • Agreement of metacholine challenge and the combined exercise/cold-air challenge

    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.

    3 months

Secondary Outcomes (1)

  • Repeatability of the combined exercise/cold-air challenge

    3 months

Other Outcomes (1)

  • Agreement of the combined exercise/cold-air challenge with the Asthma-score

    3 months

Study Arms (2)

40 patients aged 6-18 years

OTHER

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 and one exercise challenge in room temperature.

Other: Exercise challenge in a cold chamberOther: Methacholine challengeOther: Exercise challenge in room temperature

40 subjects aged 18-45 years

OTHER

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 and one exercise challenge in room temperature.

Other: Exercise challenge in a cold chamberOther: Methacholine challengeOther: Exercise challenge in room temperature

Interventions

Exercise challenge in a cold chamberOTHER

Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.

40 patients aged 6-18 years40 subjects aged 18-45 years
Methacholine challengeOTHER

nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg

40 patients aged 6-18 years40 subjects aged 18-45 years
Exercise challenge in room temperatureOTHER

Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in room temperature.

40 patients aged 6-18 years40 subjects aged 18-45 years

Eligibility Criteria

Age6 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (6)

  • Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.

    PMID: 19596563BACKGROUND

  • Anderson SD. Indirect challenge tests: Airway hyperresponsiveness in asthma: its measurement and clinical significance. Chest. 2010 Aug;138(2 Suppl):25S-30S. doi: 10.1378/chest.10-0116.

    PMID: 20668015BACKGROUND

  • Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.

    PMID: 23634861BACKGROUND

  • Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10(1):4. doi: 10.1186/1465-9921-10-4.

    PMID: 19161635BACKGROUND

  • Driessen JM, van der Palen J, van Aalderen WM, de Jongh FH, Thio BJ. Inspiratory airflow limitation after exercise challenge in cold air in asthmatic children. Respir Med. 2012 Oct;106(10):1362-8. doi: 10.1016/j.rmed.2012.06.017. Epub 2012 Jul 11.

    PMID: 22789953BACKGROUND

  • Dressler M, Friedrich T, Lasowski N, Herrmann E, Zielen S, Schulze J. Predictors and reproducibility of exercise-induced bronchoconstriction in cold air. BMC Pulm Med. 2019 May 16;19(1):94. doi: 10.1186/s12890-019-0845-3.

    PMID: 31097027DERIVED

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Johannes Schulze, MD

    Johann Wolfgang Goethe University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Pediatric Allergy and Pneumology

Study Record Dates

First Submitted

December 19, 2013

First Posted

January 3, 2014

Study Start

June 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

DE(1)