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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN MULTICENTER PARALLEL GROUPS TO EVALUATE THE EFFECTIVENESS AND SAFETY OF THE TREATMENT FOR 12 WEEKS WITH ASM981 30 MG TWICE AT DAY ADMINISTERED BY ORAL PATH IN PATIENTS WITH SEVERE BRONCHIAL ASTHMA

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN MULTICENTER PARALLEL GROUPS TO EVALUATE THE EFFECTIVENESS AND SAFETY OF THE TREATMENT FOR 12 WEEKS WITH ASM981 30 MG TWICE AT DAY ADMINISTERED BY ORAL PATH IN PATIENTS WITH SEVERE BRONCHIAL ASTHMA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-066-02
Enrollment
16
Registered
2002-11-06
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

ASM981 30 mg Type of group
ASM981 30 mg will be administered twice daily for 12 weeks in patients with severe bronchial asthma. Group name:Placebo Type of group
ASM981 30 mg placebo will be administered twice daily for 12 weeks in patients with severe bronchial asthma.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Ambulatory patients, men or women who wish to cooperate, between 18 and 70 years of age, who have given their informed consent. 2) Severe persistent asthma (GINA Guidelines, 2002 edition) 3) FEVi from 40% to 80% of the normal value predicted for the patient in Visit 1 and Visit 3. No short-acting inhaled P2 agonists should have been used for at least six hours, or inhaled long-acting p2 agonists. for at least 12 hours before the evaluation of FEVi.

Exclusion criteria

Exclusion criteria: Women with the potential to procreate: pregnancy, contraception, breastfeeding Diseases / concurrent conditions and background of other diseases / conditions

Design outcomes

Primary

MeasureTime frame
Outcome name:Forced expiratory volume in 1 second Measure:Efficacy of treatment for 12 weeks with ASM981 30 mg bid compared to placebo on forced expiratory volume in 1 second, in patients with severe asthma. Timepoints:12 week—

Secondary

MeasureTime frame
Outcome name:Pulmonary function, asthma symptoms, the rate of asthma exacerbations and the use of rescue medication and corticosteroids during the study. Measure:Effect of treatment for 12 weeks with ASM981 30 mg bid compared with placebo Timepoints:12 week—

Countries

Argentina, Belgium, Colombia, Denmark, France, Germany, Italy, Peru, Russian Federation, Singapore, Taiwan, United Kindgdom

Outcome results

None listed

Source: REPEC (via WHO ICTRP)