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

Primary Purpose

Asthma, Exercise-Induced

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Combination DSCG and Reproterol
Sponsored by
MEDA Pharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma, Exercise-Induced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kurmittelhaus der Moderne
  • Asthma Center Buchenhoehe
  • Practice Dr. T. Ginko
  • Clinic St. Georg Leipzig, Robert Koch Clinic
  • Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
  • Practice Dr. W. Schürmann
  • Institute for Pulmonary Research GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

DSCG + Reproterol

DSCG

Reproterol

Placebo

Outcomes

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).

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.

Full Information

First Posted
October 21, 2008
Last Updated
February 4, 2022
Sponsor
MEDA Pharma GmbH & Co. KG
Collaborators
ClinResearch, GmbH, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00777348
Brief Title
To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol
Acronym
AERIA
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 Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MEDA Pharma GmbH & Co. KG
Collaborators
ClinResearch, GmbH, Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Exercise-Induced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
DSCG + Reproterol
Arm Title
2
Arm Type
Active Comparator
Arm Description
DSCG
Arm Title
3
Arm Type
Active Comparator
Arm Description
Reproterol
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Combination DSCG and Reproterol
Intervention Description
1:
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Buhl, MD, Prof.
Organizational Affiliation
Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kurmittelhaus der Moderne
City
Bad Reichenhall
ZIP/Postal Code
D-83435
Country
Germany
Facility Name
Asthma Center Buchenhoehe
City
Berchtesgaden
ZIP/Postal Code
D-83471
Country
Germany
Facility Name
Practice Dr. T. Ginko
City
Bonn
ZIP/Postal Code
D-53119
Country
Germany
Facility Name
Clinic St. Georg Leipzig, Robert Koch Clinic
City
Leipzig
ZIP/Postal Code
D-04207
Country
Germany
Facility Name
Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
City
Mainz
ZIP/Postal Code
D-55131
Country
Germany
Facility Name
Practice Dr. W. Schürmann
City
Marburg
ZIP/Postal Code
D-35037
Country
Germany
Facility Name
Institute for Pulmonary Research GmbH
City
Wiesbaden
ZIP/Postal Code
D-65187
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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