Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Asthma, Exercise-Induced Drug: Combination DSCG and Reproterol Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1
DSCG + Reproterol
 Drug: Combination DSCG and Reproterol
1:
Active Comparator: 2
DSCG
 Drug: Combination DSCG and Reproterol
1:
Active Comparator: 3
Reproterol
 Drug: Combination DSCG and Reproterol
1:
Placebo Comparator: 4
Placebo
 Drug: Combination DSCG and Reproterol
1:


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00777348


Locations
Layout table for location information
Germany
Kurmittelhaus der Moderne
Bad Reichenhall, Germany, D-83435
Asthma Center Buchenhoehe
Berchtesgaden, Germany, D-83471
Practice Dr. T. Ginko
Bonn, Germany, D-53119
Clinic St. Georg Leipzig, Robert Koch Clinic
Leipzig, Germany, D-04207
Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
Mainz, Germany, D-55131
Practice Dr. W. Schürmann
Marburg, Germany, D-35037
Institute for Pulmonary Research GmbH
Wiesbaden, Germany, D-65187
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
ClinResearch, GmbH
Sanofi
Investigators
Layout table for investigator information
Principal Investigator: Roland Buhl, MD, Prof. Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Meda Pharma GmbH & Co. KG, Dr. DT Nguyen, Senior Medical Manager, Meda Pharma GmbH & Co. KG, Bad Homburg, Germany
ClinicalTrials.gov Identifier: NCT00777348    
Other Study ID Numbers: H-00982-3256
EudraCT No.: 2007-002553-23
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Reproterol
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents