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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Formoterol and Budesonide

Group Type EXPERIMENTAL

Foradil Combi (Formoterol-budesonide)

Intervention Type DRUG

Interventions

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Foradil Combi (Formoterol-budesonide)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No