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

Primary Purpose

Asthma

Status
Withdrawn
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Foradil Combi (Formoterol-budesonide)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring aerolizer, formoterol, budesonide, asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigator Site
  • Novarits Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Formoterol and Budesonide

Arm Description

Outcomes

Primary Outcome Measures

Proper use of Foradil Combi

Secondary Outcome Measures

Asthma control test
Ease of use: FSI-10 Questionnaire
Patient Satisfaction: PSAM and FSI-10
Safety: Adverse events and severe adverse events

Full Information

First Posted
October 16, 2009
Last Updated
April 19, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00997477
Brief Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
aerolizer, formoterol, budesonide, asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formoterol and Budesonide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Foradil Combi (Formoterol-budesonide)
Primary Outcome Measure Information:
Title
Proper use of Foradil Combi
Time Frame
Day 0, Day 30, Day 90
Secondary Outcome Measure Information:
Title
Asthma control test
Time Frame
Day 0, Day 30, Day 90
Title
Ease of use: FSI-10 Questionnaire
Time Frame
Day 30, Day 90
Title
Patient Satisfaction: PSAM and FSI-10
Time Frame
Evaluations will be made at visit 2 (Day 30± 1) and 3 (Day 90± 3)
Title
Safety: Adverse events and severe adverse events
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigator Site
City
Ankara
Country
Turkey
Facility Name
Novarits Investigator Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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