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

Phase 4

Withdrawn

• Conditions: Asthma
• Interventions: Drug: Foradil Combi (Formoterol-budesonide)

• Registration Number: NCT00997477
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Study Start: 2010-06
• Primary Completion: 2010-07
• Status Verified: 2016-03
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Formoterol and Budesonide	Foradil Combi (Formoterol-budesonide)	-

Primary Outcome Measures

Name	Time	Method
Proper use of Foradil Combi	Day 0, Day 30, Day 90

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Novarits Investigator Site; 🇹🇷 Istanbul, Turkey

Novartis Investigator Site; 🇹🇷 Izmir, Turkey