THE EFFECTIVENESS AND SAFETY OF AN INDIVIDUALISED SYMBICORTÒ TURBUHALERÒ MAINTENANCE DOSING REGIMEN (SYMBICORTÒ ASTHMA CONTROL PLAN) VERSUS SYMBICORTÒ TURBUHALERÒ GIVEN AS STANDARD REGULAR TWICE DAILY THERAPY. THE SYMBICORT ADJUSTABLE MAINTENANCE STUDY (SAM)

Phase 1

• Conditions: -J459 Asthma, unspecified; Asthma, unspecified; J459

• Registration Number: PER-004-02
• Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-01-07
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients currently well managed with inhaled corticosteroids and long-acting bronchodilators, or patients currently controlled with inhaled corticosteroids and short-acting bronchodilators, who present a level of symptoms indicating the need to use additional therapy, in accordance with the guidelines of the National Institute of Heart, Lung and Blood (NHLBI) for the management of asthma.

Exclusion Criteria

1) FEP <50% of predicted (if measured)
2) Patients with regular daily treatment with:> 2,000 mcg of beclomethasone dlpropionate (BDP) or fluticasone propionate or> 1,600 mcg of budesonide
3) Current requirements for oral steroids or use of oral steroids> 10 days in the previous 3 months.
4) Current use of any p-blocking therapy (including eye drops).
5) Infections of the upper respiratory tract in the previous four weeks.
6) Severe cardiovascular disease or any other significant concomitant disease that may interfere with the conduct of the study
7) Known or suspected hypersensitivity to budesonide, formoterol or inhaled lactose.
8) Pregnancy, planned pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified