Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)
A Randomized, Multi-centre, Double-blind, Double Dummy Placebo Controlled Single-dose Cross-over Study to Demonstrate That 12 and 24 µg of Formoterol Delivered by Concept1 Has a Bronchodilator Efficacy Which is Equivalent to the Same Dose of Formoterol Delivered by Aerolizer in Adult Patients With Persistent Asthma
1 other identifier
interventional
50
1 country
4
Brief Summary
This study is designed to demonstrate that formoterol 12µg and 24µg delivered by a new inhalation device (Concept1) are equivalent to the corresponding dose of formoterol delivered by the Aerolizer device in terms of efficacy, in patients with persistent asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Feb 2007
Shorter than P25 for phase_2 asthma
4 active sites
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
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 5, 2007
CompletedFirst Posted
Study publicly available on registry
March 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMarch 28, 2017
March 1, 2017
3 months
March 5, 2007
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Efficacy assessed by 12 hour Area Under the Curve (AUC) of FEV1 (forced expiratory volume in 1 second, is a measure of how well the lungs are working)
Secondary Outcomes (1)
• Efficacy assessed by forced expiratory volume in 1 second at pre-dose, 15, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours post dose
Interventions
Eligibility Criteria
You may qualify if:
- History of asthma attacks
- Forced expiratory volume in 1 second (measure of how well the lungs are working) is greater than 60% of the predicted value
You may not qualify if:
- Asthma is not stable: patients were admitted to hospital or received emergency room treatment
- Patients whose asthma drugs need changing within the month prior to the start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (4)
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bovenden--Lengler, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Wiesbaden, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharma AG
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 5, 2007
First Posted
March 6, 2007
Study Start
February 1, 2007
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
March 28, 2017
Record last verified: 2017-03