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Bronchial Challenge Test of Magnesium-treated Asthmatics

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01118923
First received: April 27, 2010
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.

The aim of this part of the project is to study the effect of a daily magnesium supplement on the grade of bronchial hyperreactivity in asthmatics.


Condition Intervention
Asthma
 Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metacholine-provocation of Mablet-treated Asthmatics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • PD20 for metacholine [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Bronchial hyperreactivity is expressed by the dose of inhaled metacholine necessary to achieve a decline of 20 % in FEV1 (Bronchial challenge test).


Secondary Outcome Measures:
  • Impulse Oscillometry for measurement of pulmonary impedance [ Time Frame: Two years ] [ Designated as safety issue: No ]
    A characteristic feature of Impulse Oscillometry is that pulmonary impedance is not derived from the respiratory signals but from the pressure-flow relationship of artificial impulse-shaped test signals which are produced by an external generator. The advantage of artificial test signals is the incomparably higher frequency contents with a relatively high consistency as far as frequency range and amplitude are concerned, so that a thorough differentiation of pulmonary function is possible.


Estimated Enrollment: 12
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Washout
Active Comparator: Mablet Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
Other Name: Mablet
Placebo Comparator: Placebo Dietary Supplement: Placebo
3 placebo-tablets daily for 12 weeks
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma with annual symptoms, bronchial hyperreactivity and positive metacholine-test (PD20<1000 microgram

Exclusion Criteria:

  • Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, major changes in eating habits within three months prior to study start and during the study period of approx. one year, various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118923

Locations
Denmark
Research Dept. of Respiratory Medicine, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
Investigators
Principal Investigator: Ronald Dahl, Professor Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark
  More Information

Publications:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01118923     History of Changes
Other Study ID Numbers: 9727d
Study First Received: April 27, 2010
Last Updated: November 1, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Bronchial challenge test
Hyperreactivity
PD20 for metacholine
Daily magnesium supplement

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Magnesium Hydroxide
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013