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Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Mometasone furoate (Drug); Concept 1 (Device); Twisthaler (Device)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.

Clinical Details

Official title: A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1)

Secondary outcome:

Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment

Forced Vital Capacity (FVC) at All Time Points

Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points

Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points

Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment

Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit

Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment

Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment

Fractional Exhaled Nitric Oxide (FeNO)

Plasma Cortisol Concentrations

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males or females who were ≥ 12 years old at the time informed consent was obtained

- Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who

additionally met the following criteria

- Patients who were receiving ICS treatment up to the maximum dose per day as indicated

in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2).

- Patients whose level of asthma control according to GINA 2010 guideline was "Partly

Controlled" or "Uncontrolled" at screening (Visit 2).

- Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at

screening (Visit 2).

- Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over

prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit 5.

- Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit 5.

Key exclusion criteria included:

- Patients diagnosed with COPD as defined by the Global Initiative for Chronic

Obstructive Lung Disease, updated 2010.

- Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed

by chest X-ray to be no longer active), or clinically significant bronchiectasis.

- Patients with any chronic conditions affecting the respiratory tract (e. g., chronic

sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

- Patients with seasonal allergy which is likely to deteriorate his/her asthma

condition during the study period judged by the investigator.

- Patients who have had a severe asthma attack/exacerbation requiring hospitalization

in the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).

- Patients who have had an emergency room visit for an asthma attack/exacerbation

within 4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).

- Patients who have ever required intubation for a severe asthma attack/exacerbation.

- Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1,

or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure). Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative Site, Kortrijk 8500, Belgium

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Additional Information

Starting date: July 2012
Last updated: April 10, 2015

Page last updated: August 23, 2015

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