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Completed

NCT Number: NCT01118923

Bronchial Challenge Test of Magnesium-treated Asthmatics

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Dept. of Respiratory Medicine, Aarhus University Hospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium supplement (magnesium hydroxide/ -oxide)

Dietary Supplement

3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS

Other names: Mablet

Placebo

Dietary Supplement

3 placebo-tablets daily for 12 weeks

Primary outcomes

  1. PD20 for metacholine

    Time frame: Two years

    Bronchial hyperreactivity is expressed by the dose of inhaled metacholine necessary to achieve a decline of 20 % in FEV1 (Bronchial challenge test).

Secondary outcomes

  1. Impulse Oscillometry for measurement of pulmonary impedance

    Time frame: Two years

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark
  • Gunnar Kjems APS

Registry information

Official study title

Metacholine-provocation of Mablet-treated Asthmatics

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 7, 2010
Registry last updated
Sep 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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