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

A Single Arm, 12 Week, Multicentre, Open Label, Phase IV Study to Evaluate Correct Use of and Patient Satisfaction From Sequential Use of Formoterol and Budesonide Inhaler Capsules Via Aerolizer™ Device in Patients With Asthma.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997477

Enrollment

Registered

2009-10-19

Start date

2010-06-30

Completion date

Unknown

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

aerolizer, formoterol, budesonide, asthma

Brief summary

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

Interventions

DRUGForadil Combi (Formoterol-budesonide)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Proper use of Foradil Combi	Day 0, Day 30, Day 90

Secondary

Measure	Time frame
Asthma control test	Day 0, Day 30, Day 90
Ease of use: FSI-10 Questionnaire	Day 30, Day 90
Patient Satisfaction: PSAM and FSI-10	Evaluations will be made at visit 2 (Day 30± 1) and 3 (Day 90± 3)
Safety: Adverse events and severe adverse events	3 Months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026