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

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.

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 Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 09, 2012

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