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To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol (AERIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777348
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : April 8, 2009
Sponsor:
Collaborators:
ClinResearch, GmbH
Sanofi
Information provided by:
MEDA Pharma GmbH & Co. KG

Tracking Information
First Submitted Date  ICMJE October 21, 2008
First Posted Date  ICMJE October 22, 2008
Last Update Posted Date April 8, 2009
Study Start Date  ICMJE November 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA). [ Time Frame: 5, 10, 15, 30 and 60 minutes after drug application ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo. [ Time Frame: 5, 10, 15, 30 and 60 minutes after drug application ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol
Official Title  ICMJE Clinical Trial to Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol in Comparison to the Single Components and Placebo in Adults With Exercise Induced Asthma Randomised, Placebo-Controlled, Double-Blind, Crossover, Multicentre Study
Brief Summary This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study. At each study visit a standardised treadmill test will be performed to provoke EIA. Before and after the challenge test pulmonary function variables (e.g. forced expiratory volume in one second (FEV1)) will be measured in order to assess the protective effect of the study medication.
Detailed Description
  • Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA).
  • Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo. In addition, the tolerability of medications will be documented.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma, Exercise-Induced
Intervention  ICMJE Drug: Combination DSCG and Reproterol
1:
Study Arms  ICMJE
  • Experimental: 1
    DSCG + Reproterol
    Intervention: Drug: Combination DSCG and Reproterol
  • Active Comparator: 2
    DSCG
    Intervention: Drug: Combination DSCG and Reproterol
  • Active Comparator: 3
    Reproterol
    Intervention: Drug: Combination DSCG and Reproterol
  • Placebo Comparator: 4
    Placebo
    Intervention: Drug: Combination DSCG and Reproterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2009)
62
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
60
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female and male subjects aged 18 - 65 years
  • Exercise induced asthma with reversible airway obstruction: twice proven EIA defined as maximum decrease in FEV1 against the baseline value of at least 20% (first test results can be obtained during the last 12 months)
  • Baseline FEV1 before challenge must be > or = 70% of the predicted FEV1

Exclusion Criteria:

Safety concerns:

  • Subjects with hypersensitivity to DSCG, reproterol, menthol, peppermint or other excipients of the study medication
  • Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner
  • Subjects with an asthma exacerbation within 4 weeks prior to the study start. Asthma exacerbation defined as use of oral (systemic) glucocorticosteroids, unscheduled consultation of a medic due to asthma, hospitalisation, or additional treatment of asthma with antibiotics
  • Eosinophilic pneumonia
  • Clinically significant cardiovascular diseases (e.g. cardiac infarction, cardiac dysrhythmia, hypertrophic obstructive cardiomyopathy, coronary heart disease…)
  • Resting blood pressure over 140/90 mmHg
  • Diastolic blood pressure after treadmill-test over 120 mmHg
  • Malignancies including phaeochromocytoma within the last 5 years
  • Severe hyperthyreosis, thyreotoxicosis, instable diabetes mellitus

Lack of suitability for the trial:

  • Subjects with seasonal asthma during their asthma season
  • Infectious disease of the upper airways within 2 weeks prior to the study and within 4 weeks prior to study in case of use of antibiotics
  • Relevant respiratory disorder other than asthma
  • Clinically significant renal, endocrine, haematological, hepatic, immunological, gastrointestinal, neurological, or psychiatric diseases
  • Any chronic disease which might influence absorption, metabolism, or excretion of the trial substances
  • Change of inhalative glucocorticosteroid dosage and / or antiasthmatic controller therapy within the last 4 weeks prior to or during the study
  • Concomitant systemic treatment with glucocorticosteroids
  • Concomitant treatment with any ß-antagonistic drug
  • Need of rescue medication within 15 min after challenge
  • Concomitant therapy with antidepressants or neuroleptics
  • Drug or alcohol abuse which would interfere with the subjects proper completion of the protocol assignment and mentally handicapped subjects
  • Smokers within the last 6 months or smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent)
  • Exposure to another investigational agent within the last 4 weeks prior to this one or during this study
  • Non-cooperative subjects not able to understand the instructions for use of the devices

Administrative reasons:

  • Lack of ability or willingness to give informed consent
  • Lack of willingness to have personal study related data collected, archived or transmitted according to protocol
  • Anticipated non-availability for study visits / procedures
  • Personnel involved in the planning or conduct of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777348
Other Study ID Numbers  ICMJE H-00982-3256
EudraCT No.: 2007-002553-23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meda Pharma GmbH & Co. KG, Dr. DT Nguyen, Senior Medical Manager, Meda Pharma GmbH & Co. KG, Bad Homburg, Germany
Study Sponsor  ICMJE MEDA Pharma GmbH & Co. KG
Collaborators  ICMJE
  • ClinResearch, GmbH
  • Sanofi
Investigators  ICMJE
Principal Investigator: Roland Buhl, MD, Prof. Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
PRS Account MEDA Pharma GmbH & Co. KG
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP