NCT00997477

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

April 20, 2017

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

October 16, 2009

Last Update Submit

April 19, 2017

Conditions

Asthma

Keywords

aerolizerformoterolbudesonideasthma

Outcome Measures

Primary Outcomes (1)

  • Proper use of Foradil Combi

    Day 0, Day 30, Day 90

Secondary Outcomes (4)

  • 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

Study Arms (1)

Formoterol and Budesonide

EXPERIMENTAL
Drug: Foradil Combi (Formoterol-budesonide)

Interventions

Foradil Combi (Formoterol-budesonide)DRUG
Formoterol and Budesonide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate persistent asthmatic patients.
  • No previous Aerolizer experience.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigator Site

Ankara, Turkey (Türkiye)

Location

Novarits Investigator Site

Istanbul, Turkey (Türkiye)

Location

Novartis Investigator Site

Istanbul, Turkey (Türkiye)

Location

Novartis Investigator Site

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 19, 2009

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Last Updated

April 20, 2017

Record last verified: 2016-03

Locations

TU(4)