Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma - Full Text View

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Mometasone Furoate	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Mometasone furoate Mometasone furoate monohydrate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Trough Forced Expiratory Volume in one second (FEV1) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.

Secondary Outcome Measures:

FEV1 at each timepoint [ Time Frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29 ] [ Designated as safety issue: No ]
Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 4 hours on Day 1 and Day 28, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minute on Day 2 and Day 29, and at pre-dose 50 minute and 15 minute on Day 8, Day 15, and Day 22.
Forced vital capacity (FVC) at each timepoint [ Time Frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29 ] [ Designated as safety issue: No ]
Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1 and Day 28, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 8, Day 15, and Day 22.
Forced Expiratory Flow between 25% and 75% (FEF25-75%) at each timepoint [ Time Frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29 ] [ Designated as safety issue: No ]
Spirometry is conducted according to the global standard. FEF25-75% is measured at pre-dose and post dose up to 4 hour on Day 1 and Day 28, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minute on Day 2 and Day 29, and at pre-dose 50 minute and 15 minute on Day 8, Day 15, and Day 22.
Trough FEV1 [ Time Frame: 1 week, 2 weeks, 3 weeks ] [ Designated as safety issue: No ]
Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 50 minute and 15 minute pre dose FEV1 readings.
Morning and evening peak expiratory flow rate (PEFR) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
PEFR is measured with portable spirometer by participants every morning and evening at home.
Asthma Control Questionnaire 5 (ACQ-5) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze.

Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
The usage of rescue medication (short acting β2-agonist) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening.
FeNO (Fractional exhaled Nitric Oxide) [ Time Frame: 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline.
Adverse events, laboratory analysis, vital signs and ECG [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Adverse event, laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (i.e. blood pressure, pulse rate), and ECG (e.g. quantitative assessments - heart rate, QTc, PRS, PR intervals)
Plasma cortisol concentrations at each timepoint [ Time Frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29 ] [ Designated as safety issue: Yes ]
Plasma cortisol to be measured at central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1 and Day 28, post dose 12 hour, 23 hour 35 minute on Day 2 and Day 29, and at pre-dose 25 minute on Day 8, Day 15, and Day 22.

Estimated Enrollment:	616
Study Start Date:	July 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mometasone furoate 80 µg Mometasone furoate 80 µg o.d. delivered via Concept1	Drug: Mometasone Furoate Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler
Experimental: Mometasone furoate 320 µg Mometasone furoate 320 µg o.d. delivered via Concept1	Drug: Mometasone Furoate Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler
Experimental: Mometasone furoate 200 µg Mometasone furoate 200 µg o.d. delivered via Twisthaler®	Drug: Mometasone Furoate Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler
Experimental: Mometasone furoate 800 µg Mometasone furoate 800 µg o.d. delivered via Twisthaler®	Drug: Mometasone Furoate Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
Patients who are receiving ICS treatment
Patients whose level of asthma control is "Partly Controlled" or "Uncontrolled"
Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value
Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
Patients who are confirmed as "ICS sensitive" by ACQ-5 questionnaire and FEV1.

Exclusion Criteria:

Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
Patients diagnosed with COPD as defined by the GOLD 2010 guidelines.
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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555151

Contacts

Contact: Novartis Pharmaceuticals	+41613241111
Contact: Novartis Pharmaceuticals

Show 193 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01555151 History of Changes
Other Study ID Numbers:	CQMF149E2201, 2011-005100-14
Study First Received:	March 13, 2012
Last Updated:	March 25, 2013
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Estonia: The State Agency of Medicine Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute for Quality - and Organizational Development in Healthcare and Medicines/National Institute of Pharmacy India: Drugs Controller General of India Japan: Pharmaceuticals and Medical Devices Agency Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Expert Board (FSBI Scientific Center of Medical Application Expertise of Ministry of Health and Social Development of the Russian Federation) Slovakia: State Institute for Drug Con Thailand: Food and Drug Administration Turkey: Ministry of Health Ukraine: Ministry of Health

Keywords provided by Novartis:

Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 17, 2013