The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo inhaler; Drug: beclomethasone; Drug: montelukast sodium; Drug: placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00911547

0476-029

2009_596

Details and patient eligibility

About

This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.

Enrollment: 642 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
• Patient was a nonsmoker
• Patient was in good general health (except for asthma)

Exclusion criteria

• Patient was hospitalized
• Patient was female who was less than 8 weeks postpartum or breast feeding
• Patient planned to move or vacation away during the study
• Patient had major surgery within 4 weeks the past 4 weeks
• Patient has donated blood or participated in a clinical trial within the past 4 weeks
• Patient was a regular user or recent abuser of alcohol or illicit drugs
• Patient was 40% over or under normal weight for height

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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642 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Montelukast + Beclomethasone

Treatment:

Drug: montelukast sodium

Drug: beclomethasone

2

Experimental group

Description:

Montelukast + Placebo inhaler

Treatment:

Drug: montelukast sodium

Drug: Placebo inhaler

3

Experimental group

Description:

Placebo tablet + Beclomethasone

Treatment:

Drug: placebo tablet

Drug: beclomethasone

4

Placebo Comparator group

Description:

Placebo tablet + Placebo inhaler

Treatment:

Drug: Placebo inhaler

Drug: placebo tablet