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

This study has been withdrawn prior to enrollment.

First Received on October 16, 2009. Last Updated on October 4, 2010 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00997477

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Foradil Combi (Formoterol-budesonide)	Phase 4

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Proper use of Foradil Combi [ Time Frame: Day 0, Day 30, Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Asthma control test [ Time Frame: Day 0, Day 30, Day 90 ] [ Designated as safety issue: No ]
Ease of use: FSI-10 Questionnaire [ Time Frame: Day 30, Day 90 ] [ Designated as safety issue: No ]
Patient Satisfaction: PSAM and FSI-10 [ Time Frame: Evaluations will be made at visit 2 (Day 30± 1) and 3 (Day 90± 3) ] [ Designated as safety issue: No ]
Safety: Adverse events and severe adverse events [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	110
Study Start Date:	June 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Formoterol and Budesonide	Drug: Foradil Combi (Formoterol-budesonide)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997477

Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Medical Department, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00997477 History of Changes
Other Study ID Numbers:	CFOR258FTR03
Study First Received:	October 16, 2009
Last Updated:	October 4, 2010
Health Authority:	Turkey: Ministry of Health

Keywords provided by Novartis:

aerolizer
formoterol
budesonide
asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012