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

NCT00777348 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-02-07

No results posted yet for this study

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

Interventions

DRUG

Combination DSCG and Reproterol

1:

Sponsors & Collaborators

  • ClinResearch, GmbH

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • MEDA Pharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Roland Buhl, MD, Prof. · Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00777348 on ClinicalTrials.gov