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Bronchial Challenge Test of Magnesium-treated Asthmatics

This study has been completed.
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: September 3, 2013
Last verified: September 2013

April 27, 2010
September 3, 2013
October 2010
March 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01118923 on ClinicalTrials.gov Archive Site
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.
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 thorugh differentiation of pulmonary function is possible.
Not Provided
Not Provided
 
Bronchial Challenge Test of Magnesium-treated Asthmatics
Metacholine-provocation of Mablet-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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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
  • Dietary Supplement: Placebo
    3 placebo-tablets daily for 12 weeks
    Other Name: Placebo
  • No Intervention: Washout
  • Active Comparator: Mablet
    Intervention: Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01118923
9727d
Yes
University of Aarhus
University of Aarhus
  • Gunnar Kjems APS
  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark
  • Aarhus University Hospital
Principal Investigator: Ronald Dahl, Professor Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark
University of Aarhus
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP