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

Tracking Information

First Received Date ^ICMJE

April 27, 2010

Last Updated Date

November 1, 2012

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01118923 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bronchial Challenge Test of Magnesium-treated Asthmatics

Official Title ^ICMJE

Metacholine-provocation of Mablet-treated Asthmatics

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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

Study Arm (s)

No Intervention: Washout
Active Comparator: Mablet
Intervention: Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
Placebo Comparator: Placebo
Intervention: Dietary Supplement: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01118923

Other Study ID Numbers ^ICMJE

9727d

Has Data Monitoring Committee

Yes

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Ronald Dahl, Professor

Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark

Information Provided By

University of Aarhus

Verification Date

November 2012

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

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