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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00997477
• Other study ID #: CFOR258FTR03
• Status: Withdrawn
• Phase: Phase 4
• First received: October 16, 2009
• Last updated: April 19, 2017
• Start date: June 2010

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Foradil Combi (Formoterol-budesonide)

Locations

Country	Name	City	State
Turkey	Novartis Investigator Site	Ankara
Turkey	Novarits Investigator Site	Istanbul
Turkey	Novartis Investigator Site	Istanbul
Turkey	Novartis Investigator Site	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome

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