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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma, Exercise-Induced
• Intervention / Treatment: Drug: Combination DSCG and Reproterol

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: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Bad Reichenhall, Germany, D-83435
    • Kurmittelhaus der Moderne
  • Berchtesgaden, Germany, D-83471
    • Asthma Center Buchenhoehe
  • Bonn, Germany, D-53119
    • Practice Dr. T. Ginko
  • Leipzig, Germany, D-04207
    • Clinic St. Georg Leipzig, Robert Koch Clinic
  • Mainz, Germany, D-55131
    • Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
  • Marburg, Germany, D-35037
    • Practice Dr. W. Schürmann
  • Wiesbaden, Germany, D-65187
    • Institute for Pulmonary Research GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 4; Placebo	Drug: Combination DSCG and Reproterol; 1:
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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	5, 10, 15, 30 and 60 minutes after drug application

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	5, 10, 15, 30 and 60 minutes after drug application

Collaborators and Investigators

• Sponsor: MEDA Pharma GmbH & Co. KG
• Collaborators: Sanofi; ClinResearch, GmbH
• Investigators: Principal Investigator: Roland Buhl, MD, Prof., Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): October 1, 2008

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (ESTIMATE): October 22, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Asthma, Exercise-Induced; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Reproterol
• Other Study ID Numbers: H-00982-3256; EudraCT No.: 2007-002553-23