Correct Use of Sequential Formoterol and Budesonide Inhaler Capsule Treatment Via Aerolizer and Patient Satisfaction in Asthmatics
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Foradil Combi (Formoterol-budesonide) (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: +41 61 324 1111
Summary
This study will evaluate the correct use of sequential formoterol and budesonide inhaler
capsule treatment via Aerolizer and patient satisfaction in adult asthmatics.
Clinical Details
Official title: 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.
Study design: Treatment, Open Label, Single Group Assignment
Primary outcome: Proper use of Foradil Combi
Secondary outcome: Asthma control testEase of use: FSI-10 Questionnaire Patient Satisfaction: PSAM and FSI-10 Safety: Adverse events and severe adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Novartis Pharmaceuticals, Phone: +41 61 324 1111
Novarits Investigator Site, Istanbul, Turkey
Novartis Investigator Site, Istanbul, Turkey
Novartis Investigator Site, Izmir, Turkey
Novartis Investigator Site, Ankara, Turkey
Additional Information
Starting date: October 2009
Last updated: October 16, 2009
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