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CompletedNCT00130351Updated May 19, 2023

A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

A Phase 3 interventional study of formoterol in Asthma, sponsored by Novartis. Completed at 12 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Novartis · Phase 3, Interventional, and Other

Phase
Phase 3
Study type
Interventional
Enrollment
155
Allocation
Non-randomized
Ages
5 Years and older
Sex
All
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Study summary

This study is designed to investigate the ability of patients with asthma to properly use a new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.

02

Conditions studied

  • Asthma

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Keywords

  • asthma, formoterol multi-dose dry powder inhaler (MDDPI)
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 155 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

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
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary
  • Patients who have a current diagnosis of asthma
  • Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a >12% increase in FEV1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at Visit 1. The administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.

Exclusion criteria

Exclusion Criteria:

  • Patients who were enrolled in study CFOR258F2304 or CFOR258F2306, or who have any experience using the Certihaler® device.
  • QTc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ECG) that in the opinion of the investigator would present a safety hazard for continuation in the study
  • Patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies
  • Other protocol-defined inclusion and exclusion criteria apply
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Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
155 participants (actual)

Interventions

  • Deviceformoterol
06

What researchers measure

Primary outcomes

  1. Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.

  2. Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.

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Study locations

12 sites
  • Allergy and Asthma Specialists Medical Group and Research Ct
    Huntington Beach, California 92647, United States
  • Allergy and Asthma Medical Group & Research Center
    San Diego, California 92123, United States
  • Allergy & Asthma Associates of Santa Clara Res. Center
    San Jose, California 95117, United States
  • Colorado Allergy and Asthma Centers, PC
    Denver, Colorado 80230, United States
  • Colorado Allergy and Asthma Centers, PC
    Englewood, Colorado 80112, United States
  • Northeast Medical Research Associates, Inc.
    North Dartmouth, Massachusetts 02747, United States
  • Northeast Medical Research Associates, Inc
    North Dartmouth, Massachusetts 02747, United States
  • Clinical Research Institute
    Minneapolis, Minnesota 55402, United States
  • The Clinical Research Center
    Saint Louis, Missouri 63141, United States
  • The Asthma & Allergy Center, PC
    Papillion, Nebraska 68046, United States
  • North Carolina Clinical Research
    Raleigh, North Carolina 27607, United States
  • Allergy Associates Research Center
    Portland, Oregon 97213, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00130351
Lead sponsor
Novartis
Collaborators
Pacira Pharmaceuticals, Inc
First posted
Aug 15, 2005
Start date
Jul 2005
Primary completion
Aug 2005
Completion
Aug 2005
Last update
May 19, 2023

Study contacts

Novartis Pharmaceuticals
study chair · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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