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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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Mometasone furoate

Concept 1

Twisthaler

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Mometasone furoate 80 μg

Mometasone furoate 200 µg

Mometasone furoate 320 µg

Mometasone furoate 800 µg

Arm Description

Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.

Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.

Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.

Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1)

Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.

Secondary Outcome Measures

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

Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.

Forced Vital Capacity (FVC) at All Time Points

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

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

The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.

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

Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.

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

Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.

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

Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).

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

Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

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

Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication. The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use.

Fractional Exhaled Nitric Oxide (FeNO)

FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.

Plasma Cortisol Concentrations

Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L

Full Information

NCT ID

NCT01555151

First Posted

March 13, 2012

Last Updated

April 10, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01555151

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

739 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mometasone furoate 80 μg

Arm Type

Experimental

Arm Description

Arm Title

Mometasone furoate 200 µg

Arm Type

Experimental

Arm Description

Arm Title

Mometasone furoate 320 µg

Arm Type

Experimental

Arm Description

Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.

Arm Title

Mometasone furoate 800 µg

Arm Type

Experimental

Arm Description

Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Mometasone furoate

Other Intervention Name(s)

QMF149

Intervention Description

Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device

Intervention Type

Device

Intervention Name(s)

Concept 1

Intervention Description

A single dose dry powder inhaler (SDDPI)

Intervention Type

Device

Intervention Name(s)

Twisthaler

Intervention Description

A single dose dry powder inhaler (SDDPI)

Primary Outcome Measure Information:

Title

Trough Forced Expiratory Volume in 1 Second (FEV1)

Description

Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.

Time Frame

Day 29

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Days 8, 15 and 22

Title

Forced Vital Capacity (FVC) at All Time Points

Description

Time Frame

Days 1, 8, 15, 22, 28 and 29 at all time points

Title

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

Description

Time Frame

Days 1, 8, 15, 22, 28 and 29 at all time points

Title

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

Description

Time Frame

Days 1, 8, 15, 22, 28 and 29 at all time points

Title

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

Description

Time Frame

Baseline and week 4

Title

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

Description

Time Frame

Baseline, days 8,15,22 and 29

Title

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

Description

Time Frame

Baseline and 4 weeks

Title

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

Description

Time Frame

4 weeks

Title

Fractional Exhaled Nitric Oxide (FeNO)

Description

FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.

Time Frame

Days 15 and 29

Title

Plasma Cortisol Concentrations

Description

Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L

Time Frame

Baseline, days 1 and 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Niagara Falls

State/Province

Ontario

ZIP/Postal Code

L2G 1J4

Country

Canada

Facility Name

Novartis Investigative Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Novartis Investigative Site

City

Mirabel

State/Province

Quebec

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1L5

Country

Canada

Facility Name

Novartis Investigative Site

City

Trois-Rivières

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

GIV 4M6

Country

Canada

Facility Name

Novartis Investigative Site

City

Kohtla-Järve

ZIP/Postal Code

30321

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10696

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14050

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14057

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45355

Country

Germany

Facility Name

Novartis Investigative Site

City

Goch

ZIP/Postal Code

47574

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30317

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

4207

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebeck

ZIP/Postal Code

23562

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80539

Country

Germany

Facility Name

Novartis Investigative Site

City

Reinfeld

ZIP/Postal Code

23858

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Novartis Investigative Site

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1041

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1135

Country

Hungary

Facility Name

Novartis Investigative Site

City

Cegled

ZIP/Postal Code

2700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kistelek

ZIP/Postal Code

6760

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Makó

ZIP/Postal Code

6900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mohacs

ZIP/Postal Code

7700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Monor

ZIP/Postal Code

2200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mosonmagyarovar

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szikszo

ZIP/Postal Code

3800

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Százhalombatta

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Novartis Investigative Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 010

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560043

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

Country

India

Facility Name

Novartis Investigative Site

City

Mysore

State/Province

Karnataka

ZIP/Postal Code

570004

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411 014

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641 045.

Country

India

Facility Name

Novartis Investigative Site

City

Vellore

State/Province

Tamil Nadu

ZIP/Postal Code

632 004

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

ZIP/Postal Code

302001

Country

India

Facility Name

Novartis Investigative Site

City

Karamsad

ZIP/Postal Code

388225

Country

India

Facility Name

Novartis Investigative Site

City

Ludhiana

ZIP/Postal Code

141001

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

ZIP/Postal Code

400012

Country

India

Facility Name

Novartis Investigative Site

City

Thrissur

ZIP/Postal Code

680002

Country

India

Facility Name

Novartis Investigative Site

City

Toon-shi

State/Province

Ehime

ZIP/Postal Code

791-0281

Country

Japan

Facility Name

Novartis Investigative Site

City

Mizunami-city

State/Province

Gifu

ZIP/Postal Code

509-6134

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuyama-shi

State/Province

Hiroshima

ZIP/Postal Code

720-0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Kitahiroshima-shi

State/Province

Hokkaido

ZIP/Postal Code

061-1121

Country

Japan

Facility Name

Novartis Investigative Site

City

Obihiro-shi

State/Province

Hokkaido

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Obihiro-shi

State/Province

Hokkaido

ZIP/Postal Code

080-0805

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

004-0022

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

065-0025

Country

Japan

Facility Name

Novartis Investigative Site

City

Tomakomai

State/Province

Hokkaido

ZIP/Postal Code

053-8506

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe-shi

State/Province

Hyogo

ZIP/Postal Code

653-0021

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawasaki-shi

State/Province

Kanagawa

ZIP/Postal Code

211-0041

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurashiki-city

State/Province

Okayama

ZIP/Postal Code

712-8064

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurashiki-shi

State/Province

Okayama

ZIP/Postal Code

713-8103

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

530-0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakai-city

State/Province

Osaka

ZIP/Postal Code

591-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0853

Country

Japan

Facility Name

Novartis Investigative Site

City

Toyonaka-city

State/Province

Osaka

ZIP/Postal Code

560-0082

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

102-0083

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novartis Investigative Site

City

Hachioji-city

State/Province

Tokyo

ZIP/Postal Code

192-0032

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

140-0011

Country

Japan

Facility Name

Novartis Investigative Site

City

Tachikawa

State/Province

Tokyo

ZIP/Postal Code

190-0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima-ku

State/Province

Tokyo

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

Novartis Investigative Site

City

Rezekne

State/Province

ZIP/Postal Code

LV-4600

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Talsi

State/Province

ZIP/Postal Code

LV3201

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1004

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

44320

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

State/Province

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92231

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kuching

State/Province

Sarawak

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kota Kinabalu

ZIP/Postal Code

88586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Almere

State/Province

The Netherlands

ZIP/Postal Code

1311 RL

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Eindhoven

State/Province

The Netherlands

ZIP/Postal Code

5616GB

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leiderdorp

State/Province

The Netherlands

ZIP/Postal Code

2352 RA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

State/Province

The Netherlands

ZIP/Postal Code

3021 HC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Zoetermeer

State/Province

The Netherlands

ZIP/Postal Code

2724 EK

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Geleen

ZIP/Postal Code

6166 GR

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-445

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-954

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-637

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

95-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Novartis Investigative Site

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

01-868

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-445

Country

Poland

Facility Name

Novartis Investigative Site

City

St. Petersburg

State/Province

Nizhny Novgorod

ZIP/Postal Code

194356

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ekaterinburg

State/Province

Russia

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

State/Province

Russia

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

State/Province

Russia

ZIP/Postal Code

109240

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sankt-Peterburg

State/Province

Russia

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

State/Province

Russia

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bojnice

State/Province

Slovak Republic

ZIP/Postal Code

972 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

831 03

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

83101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Levice

State/Province

Slovak republic

ZIP/Postal Code

934 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Hradok

State/Province

Slovak Republic

ZIP/Postal Code

033 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

State/Province

Slovak Republic

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Roznava

State/Province

Slovak Republic

ZIP/Postal Code

4801

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Surany

State/Province

Slovak Republic

ZIP/Postal Code

942 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trencin

State/Province

Slovak Republic

ZIP/Postal Code

91108

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

833 40

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Poprad

ZIP/Postal Code

05845

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Ruzomberok

ZIP/Postal Code

034 26

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Muang

ZIP/Postal Code

11000

Country

Thailand

Facility Name

Novartis Investigative Site

City

Muang

ZIP/Postal Code

30000

Country

Thailand

Facility Name

Novartis Investigative Site

City

Rajathevee

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Ratchathewi

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Novartis Investigative Site

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

Novartis Investigative Site

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

34890

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Talas / Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Novartis Investigative Site

City

Dnipropetrovsk

ZIP/Postal Code

49066

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Dnipropetrovsk

ZIP/Postal Code

49074

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Donetsk

ZIP/Postal Code

83003

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kharkiv

ZIP/Postal Code

61098

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kharkiv

ZIP/Postal Code

61124

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

1004

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

3680

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

4050

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Vinnytsia

ZIP/Postal Code

20129

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial