Clinical trial NCT01118923: Bronchial Challenge Test of Magnesium-treated Asthmatics
Official title: Metacholine-provocation of Mablet-treated Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Bronchial challenge test
Hyperreactivity
PD20 for metacholine
Daily magnesium supplement
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Gunnar Kjems APS
name: GCP-unit at Aarhus University Hospital, Aarhus, Denmark
name: Aarhus University Hospital
First posted: 2010-05-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: PD20 for metacholine
timeFrame: Two years
Secondary outcomes:
measure: Impulse Oscillometry for measurement of pulmonary impedance
timeFrame: Two years
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Research Dept. of Respiratory Medicine, Aarhus University Hospital
Study officials:
affiliation: Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark
name: Ronald Dahl, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Abreu Gonzalez J, Hernandez Garcia C, Abreu Gonzalez P, Martin Garcia C, Jimenez A. [Effect of intravenous magnesium sulfate on chronic obstructive pulmonary disease exacerbations requiring hospitalization: a randomized placebo-controlled trial]. Arch Bronconeumol. 2006 Aug;42(8):384-7. doi: 10.1016/s1579-2129(06)60551-x. Spanish.