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

This study is not yet open for participant recruitment.

Verified by Novartis, October 2009

First Received: October 16, 2009 No Changes Posted

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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
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 Arformoterol 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:	October 2009
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Formoterol and Budesonide: Experimental	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

Contacts

Contact: Novartis Pharmaceuticals

+41 61 324 1111

Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

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

Keywords provided by Novartis:

aerolizer
formoterol
budesonide
asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010