Trial record 5 of 33 for:    "Asthma, Exercise-Induced"

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

This study has been completed.
Sponsor:
Collaborators:
ClinResearch
Sanofi
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00777348
First received: October 21, 2008
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Asthma, Exercise-Induced
Drug: Combination DSCG and Reproterol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT00777348

Locations
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
Sanofi
Investigators
Principal Investigator: Roland Buhl, MD, Prof. Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: H-00982-3256, EudraCT No.: 2007-002553-23
Study First Received: October 21, 2008
Last Updated: April 7, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cromolyn Sodium
Reproterol
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 21, 2014