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

NCT00777348 | Completed Phase 2 DMC

• 2 other identifiers: H-00982-3256EudraCT No.: 2007-002553-23
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 7

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.

Conditions

Asthma, Exercise-Induced

Outcome Measures

Primary Outcomes (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).

  5, 10, 15, 30 and 60 minutes after drug application

Secondary Outcomes (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.

  5, 10, 15, 30 and 60 minutes after drug application

Study Arms (4)

1

EXPERIMENTAL

DSCG + Reproterol

Drug: Combination DSCG and Reproterol

2

ACTIVE COMPARATOR

DSCG

Drug: Combination DSCG and Reproterol

3

ACTIVE COMPARATOR

Reproterol

Drug: Combination DSCG and Reproterol

4

PLACEBO COMPARATOR

Placebo

Drug: Combination DSCG and Reproterol

Interventions

Combination DSCG and Reproterol DRUG

1:

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MEDA Pharma GmbH & Co. KG: lead
• ClinResearch, GmbH: collaborator
• Sanofi: collaborator

Study Sites (7)

Kurmittelhaus der Moderne

Bad Reichenhall, D-83435, Germany

Location

Asthma Center Buchenhoehe

Berchtesgaden, D-83471, Germany

Location

Practice Dr. T. Ginko

Bonn, D-53119, Germany

Location

Clinic St. Georg Leipzig, Robert Koch Clinic

Leipzig, D-04207, Germany

Location

Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz

Mainz, D-55131, Germany

Location

Practice Dr. W. Schürmann

Marburg, D-35037, Germany

Location

Institute for Pulmonary Research GmbH

Wiesbaden, D-65187, Germany

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

reproterol

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Roland Buhl, MD, Prof.

  Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: November 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 7, 2022

Record last verified: 2009-04

Locations

DE (7)