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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01555151 |
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Date of registration:
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13/03/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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739 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01555151 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Canada
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Estonia
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Germany
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Hungary
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India
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Japan
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Latvia
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Lithuania
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Malaysia
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Netherlands
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Poland
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Russian Federation
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Slovakia
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Thailand
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Turkey
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Ukraine
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Device: Twisthaler
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Device: Concept 1
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Drug: Mometasone furoate
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Primary Outcome(s)
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Trough Forced Expiratory Volume in 1 Second (FEV1)
[Time Frame: Day 29]
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Secondary Outcome(s)
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Forced Vital Capacity (FVC) at All Time Points
[Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points]
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Plasma Cortisol Concentrations
[Time Frame: Baseline, days 1 and 28]
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Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment
[Time Frame: Days 8, 15 and 22]
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Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment
[Time Frame: Baseline and 4 weeks]
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Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points
[Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points]
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Fractional Exhaled Nitric Oxide (FeNO)
[Time Frame: Days 15 and 29]
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Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit
[Time Frame: Baseline, days 8,15,22 and 29]
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Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment
[Time Frame: 4 weeks]
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Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment
[Time Frame: Baseline and week 4]
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Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points
[Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points]
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Secondary ID(s)
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2011-005100-14
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CQMF149E2201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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