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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997477
Recruitment Status : Withdrawn
First Posted : October 19, 2009
Last Update Posted : April 20, 2017
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Foradil Combi (Formoterol-budesonide) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : June 2010
Estimated Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Formoterol and Budesonide Drug: Foradil Combi (Formoterol-budesonide)

Primary Outcome Measures :
  1. Proper use of Foradil Combi [ Time Frame: Day 0, Day 30, Day 90 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00997477

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Medical Department, Novartis Pharmaceuticals Identifier: NCT00997477    
Other Study ID Numbers: CFOR258FTR03
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: March 2016
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action