Correct Use of Sequential Formoterol and Budesonide Inhaler Capsule Treatment Via Aerolizer and Patient Satisfaction in Asthmatics

Novartis

Status and phase

Withdrawn

Phase 4

Conditions

Asthma

Treatments

Drug: Foradil Combi (Formoterol-budesonide)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00997477

CFOR258FTR03

Details and patient eligibility

About

This study will evaluate the correct use of sequential formoterol and budesonide inhaler capsule treatment via Aerolizer and patient satisfaction in adult asthmatics.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Moderate persistent asthmatic patients.
No previous Aerolizer experience.

Exclusion criteria

Life-threatening asthma: A subject must not have life-threatening asthma as a history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest or hypoxic seizures, or asthma-related syncopal episode(s).
Worsening of asthma: A subject must not have experienced a worsening of asthma which involved a hospitalization within 6 months of screening, or an emergency room visit three or more times in the past 6 months, or use of oral corticosteroids for worsening asthma within 3 months of screening.
Unstable asthma: During screening period, a patient requires the use of >8 puffs/day of salbutamol 100 mcg per actuation pMDI on two consecutive days.
A subject must not have had an upper respiratory tract infection within 4 weeks of screening.
FEV1< 60% at screening.

Other protocol-defined inclusion/exclusion criteria may apply.