Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000502336
Ethics application status
Approved
Date submitted
3/09/2008
Date registered
30/09/2008
Date last updated
30/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of inhaled magnesium on pulmonary function and walking distance of patients with stable chronic obstructive pulmonary disease (COPD).
Scientific title
Effects of inhaled magnesium on pulmonary function and walking distance of patients with stable chronic obstructive pulmonary disease (COPD).
Secondary ID [1] 707 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 3638 0
Condition category
Condition code
Respiratory 3802 3802 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients are going to be evaluated in two occasions within a crossover design
First treatment day:
#Inhalation of 300 mg of magnesium sulphate for 10 minutes.
# A 10 minute rest period
# Spirometry test
# Inhalation of 2,5 mg of salbutamol for 10 minutes after the spirometry.
# A second spirometry 10 minutes after the end of the inhalation of salbutamol
# A six minute walk test 10 minutes after the end of the last inhalation.
All treatments are going to be administered only one time. A 48 hours wash-out period is going to respected between the first and second treatment days.
Intervention code [1] 3350 0
Treatment: Drugs
Comparator / control treatment
The same patients are going to receive a treatment with placebo in a second occasion.
All patients are going to be evaluated in two occasions within a crossover design. Second treatment day:
#Inhalation of 5m of saline for 10 minutes.
# A 10 minute rest period
# Spirometry test
# Inhalation of 2,5 mg of salbutamol for 10 minutes after the spirometry.
# A second spirometry 10 minutes after the end of the inhalation of salbutamol
# A six minute walk test 10 minutes after the end of the last inhalation.
All treatments are going to be administered only one time.
Control group
Active

Outcomes
Primary outcome [1] 4699 0
Change in forced expiratory volume at the first second (FEV1)
Timepoint [1] 4699 0
Baseline and ten minutes after inhalation of magnesium or placebo
Secondary outcome [1] 7925 0
Walking distance in a 6 minute walking test
Timepoint [1] 7925 0
Ten minutes after the end of the last inhalation.

Eligibility
Key inclusion criteria
Patients with chronic obstructive pulmonary disase of any severity.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active smokers; patients with any cardiac condition, diabetes mellitus or kidney failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization. The volunteers are going to choose one among several opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 1185 0
Brazil
State/province [1] 1185 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 3814 0
Hospital
Name [1] 3814 0
Hospital das Clinicas de Ribeirao Preto
Country [1] 3814 0
Brazil
Primary sponsor type
Individual
Name
José Antônio Baddini Martinez MD, PhD
Address
Avenida Bandeirantes 3900, Ribeirão Preto, São Paulo
Country
Brazil
Secondary sponsor category [1] 3423 0
Hospital
Name [1] 3423 0
Hospital das Clinicas de Ribeirao Preto
Address [1] 3423 0
Avenida Bandeirantes 3900, Ribeirao Preto, Sao Paulo
Country [1] 3423 0
Brazil
Other collaborator category [1] 398 0
Individual
Name [1] 398 0
Camila Benedet
Address [1] 398 0
Avenida Bandeirantes 3900, Ribeirao Preto, Sao Paulo
Country [1] 398 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5874 0
Comite de Etica do Hospital das Clinicas de Ribeirao Preto
Ethics committee address [1] 5874 0
Avenida Bandeirantes 3900, Ribeirao Preto, Sao Paulo
Ethics committee country [1] 5874 0
Brazil
Date submitted for ethics approval [1] 5874 0
Approval date [1] 5874 0
04/03/2008
Ethics approval number [1] 5874 0

Summary
Brief summary
Twenty four COPD patients in stable clinical conditions, for at least one month, are going to be enrolled in the study. The tests are going to be performed in two ocasions, at least two days apart. All the patients will go to the pulmonary function laboratory without use of any bronchodilator for at least 12 hours. They are going to perform a simple spirometry at baseline and minutes after an inhalation with 300 mg of magnesium or placebo. After a second spirometry, the patients are going to receive an additional inhalation with salbutamol 2.5 mg. The patients are going to perform a third spirometry minutes after the last inhalation. Finally they are going to perform a six minute walk test in both ocasions.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 28896 0
Address 28896 0
Country 28896 0
Phone 28896 0
Fax 28896 0
Email 28896 0
Contact person for public queries
Name 12053 0
José Antônio Baddini Martinez MD, PhD
Address 12053 0
Avenida Bandeirantes 3900, Ribeirão Preto, São Paulo
Country 12053 0
Brazil
Phone 12053 0
16-36022531
Fax 12053 0
16-36336695
Email 12053 0
[email protected]
Contact person for scientific queries
Name 2981 0
José Antônio Baddini Martinez
Address 2981 0
Avenida Bandeirantes 3900, Ribeirão Preto, São Paulo
Country 2981 0
Brazil
Phone 2981 0
16-36022531
Fax 2981 0
16-36336695
Email 2981 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.