Bronchial Challenge Test of Magnesium-treated Asthmatics
|ClinicalTrials.gov Identifier: NCT01118923|
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : September 4, 2013
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 or disease||Intervention/treatment||Phase|
|Asthma||Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide) Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Metacholine-provocation of Mablet-treated Asthmatics|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|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
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118923
|Research Dept. of Respiratory Medicine, Aarhus University Hospital|
|Aarhus C, Denmark, 8000|
|Principal Investigator:||Ronald Dahl, Professor||Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark|