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

April 19, 2017 updated by: Novartis Pharmaceuticals

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Novartis Investigator Site
      • Istanbul, Turkey
        • Novartis Investigator Site
      • Istanbul, Turkey
        • Novarits Investigator Site
      • Izmir, Turkey
        • Novartis Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Formoterol and Budesonide
Drug: Foradil Combi (Formoterol-budesonide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proper use of Foradil Combi
Time Frame: Day 0, Day 30, Day 90
Day 0, Day 30, Day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
Asthma control test
Time Frame: Day 0, Day 30, Day 90
Day 0, Day 30, Day 90
Ease of use: FSI-10 Questionnaire
Time Frame: Day 30, Day 90
Day 30, Day 90
Patient Satisfaction: PSAM and FSI-10
Time Frame: Evaluations will be made at visit 2 (Day 30± 1) and 3 (Day 90± 3)
Evaluations will be made at visit 2 (Day 30± 1) and 3 (Day 90± 3)
Safety: Adverse events and severe adverse events
Time Frame: 3 Months
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFOR258FTR03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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