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.”

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

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment

Study Primary Completion Date: July 2010

Intervention(s) in this Clinical Trial

• Drug: Foradil Combi (Formoterol-budesonide)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Formoterol and Budesonide

Primary Measures

• Proper use of Foradil Combi
  • Time Frame: Day 0, Day 30, Day 90
    Safety Issue?: No

Secondary Measures

• Asthma control test
  • Time Frame: Day 0, Day 30, Day 90
    Safety Issue?: No
• Ease of use: FSI-10 Questionnaire
  • Time Frame: Day 30, Day 90
    Safety Issue?: No
• Patient Satisfaction: PSAM and FSI-10
  • Time Frame: Evaluations will be made at visit 2 (Day 30± 1) and 3 (Day 90± 3)
    Safety Issue?: No
• Safety: Adverse events and severe adverse events
  • Time Frame: 3 Months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Overall Contact: Novartis Pharmaceuticals +41 61 324 1111 

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00997477

Study ID Number: CFOR258FTR03

ClinicalTrials.gov Identifier: NCT00997477

Health Authority: Turkey: Ministry of Health