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A MULTI-CENTER STUDY OF 52 WEEKS, RANDOMIZED, DOUBLE-BLIND, DOUBLED MASKED, CONTROLLED WITH PLACEBO AND PARALLEL GROUPS, TO COMPARE THE EFFECTIVENESS AND TOLERABILITY OF THE COMBINATION WITH SALMETEROL / PROPIONATO DE FLUTICASONA (SERETIDE / VIANI / ADV)

A MULTI-CENTER STUDY OF 52 WEEKS, RANDOMIZED, DOUBLE-BLIND, DOUBLED MASKED, CONTROLLED WITH PLACEBO AND PARALLEL GROUPS, TO COMPARE THE EFFECTIVENESS AND TOLERABILITY OF THE COMBINATION WITH SALMETEROL / PROPIONATO DE FLUTICASONA (SERETIDE / VIANI / ADV)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-026-02
Enrollment
13
Registered
2002-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

A placebo inhalation with the DISKUS / ACCUHALER inhaler in the morning and A placebo inhalation with the DISKUS / ACCUHALER inhaler at night. Group name:fluticasone propionate Type of group
Inhalation of fluticasone propionate at a rate of 100 mcg / dose with the DISKUS / ACCUHALER inhaler in the morning and 1 inhalation of fluticasone propionate at a rate of 100 mcg / dose with the DISKUS / ACCUHALER inhaler at night.

Sponsors

GLAXOSMITHKLINE PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Male or female with an age> 12 years • Who are currently receiving b2 short-acting inhaled agonists. • That they are able to comply with the therapy and correctly complete the Daily Registration Cards. • Have a documented history of asthma for a period of at least 6 months.

Exclusion criteria

Exclusion criteria: • That they have received research medication in the study within 4 weeks prior to the first visit or that they are participating concurrently in another clinical trial. • That they are using oral / parenteral corticosteroids or deposit in a period of 12 weeks prior to the first visit. • That they are using inhaled corticosteroids within 12 weeks of the first visit. • That they are using receptor antagonists for leukotrienes within 12 weeks prior to the first visit.

Design outcomes

Primary

MeasureTime frame
Outcome name:Symptoms of asthma exacerbation. Measure:Frequency of asthma exacerbations over the weeks. Timepoints:1 - 52 weeks

Secondary

MeasureTime frame
Outcome name:Forced expiratory flow forced vital capacity Measure:Forced forced expiratory flow (FEF) between 25% and 75% of forced vital capacity Timepoints:52 week

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)