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CompletedNCT00443482Updated Mar 28, 2017

Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)

A Phase 2 interventional study of formoterol in Asthma, sponsored by Novartis. Completed at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • adults
  • B2 agonist
  • formoterol
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 50 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

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Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
50 participants (actual)

Interventions

  • Drugformoterol
06

What researchers measure

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

07

Study locations

4 sites
  • Novartis Investigative Site
    Berlin, Germany
  • Novartis Investigative Site
    Bovenden--Lengler, Germany
  • Novartis Investigative Site
    Marburg, Germany
  • Novartis Investigative Site
    Wiesbaden, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00443482
Lead sponsor
Novartis
First posted
Mar 6, 2007
Start date
Feb 2007
Primary completion
May 2007
Completion
May 2007
Last update
Mar 28, 2017

Study contacts

Novartis Pharma AG
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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