AsthmaPhase 2NCT01555151
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma
A Phase 2 study testing Mometasone furoate, Concept 1 and Twisthaler in people with Asthma, run by Novartis Pharmaceuticals at 165 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mometasone furoate, Concept 1 and Twisthaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 165 sitesin 17 countries
- Study dates
- Jul 2012to Jul 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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
Trial locations and contacts
165 sites in 17 countries.
165 sites in 17 countries
Hungary26 sites
Novartis Investigative Site
Baja, 6500
Novartis Investigative Site
Balassagyarmat, Hungary, 2660
Novartis Investigative Site
Budapest, Hungary, 1036
Novartis Investigative Site
Budapest, Hungary, 1041
Novartis Investigative Site
Budapest, Hungary, 1122
Novartis Investigative Site
Budapest, Hungary, 1135
Novartis Investigative Site
Budapest, 1033
Novartis Investigative Site
Budapest, 1121
Novartis Investigative Site
Cegléd, Hungary, 2700
Novartis Investigative Site
Debrecen, Hungary, 4031
Novartis Investigative Site
Gödöllő, 2100
Novartis Investigative Site
Győr, 9024
Novartis Investigative Site
Gyula, 5700
Novartis Investigative Site
Kistelek, 6760
Novartis Investigative Site
Komárom, Hungary, 2900
Novartis Investigative Site
Makó, 6900
Novartis Investigative Site
Mohács, 7700
Novartis Investigative Site
Monor, Hungary, 2200
Novartis Investigative Site
Mosonmagyaróvár, 9200
Novartis Investigative Site
Nagykanizsa, 8800
Novartis Investigative Site
Nyíregyháza, Hungary, 4400
Novartis Investigative Site
Százhalombatta, Hungary, 2440
Novartis Investigative Site
Szeged, Hungary, 6722
Novartis Investigative Site
Szikszó, Hungary, 3800
Novartis Investigative Site
Szombathely, 9700
Novartis Investigative Site
Törökbálint, Hungary, 2045
Japan24 sites
Novartis Investigative Site
Chiyoda-ku, Tokyo, 102-0083
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0027
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0028
Novartis Investigative Site
Fukuyama-shi, Hiroshima, 720-0001
Novartis Investigative Site
Hachiōji, Tokyo, 192-0032
Novartis Investigative Site
Kawasaki-shi, Kanagawa, 211-0041
Novartis Investigative Site
Kitahiroshima-shi, Hokkaido, 061-1121
Novartis Investigative Site
Kobe, Hyōgo, 653-0021
Novartis Investigative Site
Kurashiki, Okayama-ken, 712-8064
Novartis Investigative Site
Kurashiki-shi, Okayama-ken, 713-8103
Novartis Investigative Site
Mizunami, Gifu, 509-6134
Novartis Investigative Site
Obihiro-shi, Hokkaido, 080-0013
Novartis Investigative Site
Obihiro-shi, Hokkaido, 080-0805
Novartis Investigative Site
Osaka, Osaka, 530-0001
Novartis Investigative Site
Sakai, Osaka, 591-8555
Novartis Investigative Site
Sapporo, Hokkaido, 004-0022
Novartis Investigative Site
Sapporo, Hokkaido, 065-0025
Novartis Investigative Site
Shinagawa-ku, Tokyo, 140-0011
Novartis Investigative Site
Suita, Osaka, 565-0853
Novartis Investigative Site
Tachikawa, Tokyo, 190-0013
Novartis Investigative Site
Tomakomai, Hokkaido, 053-8506
Novartis Investigative Site
Toon-shi, Ehime, 791-0281
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0014
Novartis Investigative Site
Toyonaka, Osaka, 560-0082
Germany17 sites
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Berlin, Germany, 10696
Novartis Investigative Site
Berlin, Germany, 10717
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Berlin, Germany, 14050
Novartis Investigative Site
Berlin, Germany, 14057
Novartis Investigative Site
Dresden, 01069
Novartis Investigative Site
Essen, Germany, 45355
Novartis Investigative Site
Goch, 47574
Novartis Investigative Site
Hamburg, Germany, 22143
Novartis Investigative Site
Hamburg, 20253
Novartis Investigative Site
Hanover, 30317
Novartis Investigative Site
Leipzig, Germany, 4207
Novartis Investigative Site
Lübeck, Germany, 23562
Novartis Investigative Site
München, 80539
Novartis Investigative Site
Reinfeld, Germany, 23858
Novartis Investigative Site
Schwerin, Germany, 19055
Slovakia14 sites
Novartis Investigative Site
Bojnice, Slovak Republic, 972 01
Novartis Investigative Site
Bratislava, Slovak Republic, 831 03
Novartis Investigative Site
Bratislava, Slovak Republic, 83101
Novartis Investigative Site
Bratislava, 833 40
Novartis Investigative Site
Košice, Slovak Republic, 040 01
Novartis Investigative Site
Levice, Slovak Republic, 934 01
Novartis Investigative Site
Liptovský Hrádok, Slovak Republic, 033 01
Novartis Investigative Site
Martin, Slovakia, 036 59
Novartis Investigative Site
Nitra, Slovak Republic, 949 01
Novartis Investigative Site
Poprad, Slovakia, 05845
Novartis Investigative Site
Rožňava, Slovak Republic, 4801
Novartis Investigative Site
Ružomberok, Slovakia, 034 26
Novartis Investigative Site
Šurany, Slovak Republic, 942 01
Novartis Investigative Site
Trenčín, Slovak Republic, 91108
India12 sites
Novartis Investigative Site
Bangalore, Karnataka, 560 010
Novartis Investigative Site
Bangalore, Karnataka, 560043
Novartis Investigative Site
Bangalore, Karnataka, 560054
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641 045.
Novartis Investigative Site
Jaipur, India, 302001
Novartis Investigative Site
Karamsad, India, 388225
Novartis Investigative Site
Ludhiana, India, 141001
Novartis Investigative Site
Mysore, Karnataka, 570004
Novartis Investigative Site
Nagpur, India, 400012
Novartis Investigative Site
Pune, Maharashtra, 411 014
Novartis Investigative Site
Thrissur, India, 680002
Novartis Investigative Site
Vellore, Tamil Nadu, 632 004
Ukraine12 sites
Novartis Investigative Site
Dnipropetrovsk, Ukraine, 49066
Novartis Investigative Site
Dnipropetrovsk, Ukraine, 49074
Novartis Investigative Site
Donetsk, Ukraine, 83003
Novartis Investigative Site
Kharkiv, Ukraine, 61039
Novartis Investigative Site
Kharkiv, Ukraine, 61098
Novartis Investigative Site
Kharkiv, Ukraine, 61124
Novartis Investigative Site
Kyiv, Ukraine, 04050
Novartis Investigative Site
Kyiv, Ukraine, 1004
Novartis Investigative Site
Kyiv, Ukraine, 3680
Novartis Investigative Site
Kyiv, Ukraine, 4050
Novartis Investigative Site
Vinnytsia, Ukraine, 20129
Novartis Investigative Site
Vinnytsia, Ukraine, 21029
Poland10 sites
Novartis Investigative Site
Bialystok, Poland, 15-445
Novartis Investigative Site
Gdansk, 80-952
Novartis Investigative Site
Katowice, Poland, 40-954
Novartis Investigative Site
Krakow, Poland, 30-510
Novartis Investigative Site
Krakow, Poland, 31-637
Novartis Investigative Site
Lodz, Poland, 95-100
Novartis Investigative Site
Poznan, Poland, 60-693
Novartis Investigative Site
Skierniewice, 96-100
Novartis Investigative Site
Warsaw, Poland, 01-868
Novartis Investigative Site
Wroclaw, Poland, 50-445
Netherlands7 sites
Novartis Investigative Site
Almere Stad, The Netherlands, 1311 RL
Novartis Investigative Site
Eindhoven, The Netherlands, 5616GB
Novartis Investigative Site
Geleen, 6166 GR
Novartis Investigative Site
Hoofddorp, 2134 TM
Novartis Investigative Site
Leiderdorp, The Netherlands, 2352 RA
Novartis Investigative Site
Rotterdam, The Netherlands, 3021 HC
Novartis Investigative Site
Zoetermeer, The Netherlands, 2724 EK
Russia7 sites
Novartis Investigative Site
Kazan', Russia, 420012
Novartis Investigative Site
Moscow, Russia, 109240
Novartis Investigative Site
Saint Petersburg, Nizhny Novgorod Oblast, 194356
Novartis Investigative Site
Saint Petersburg, Russia, 194044
Novartis Investigative Site
Saint Petersburg, Russia, 197022
Novartis Investigative Site
Yaroslavl, 150003
Novartis Investigative Site
Yekaterinburg, Russia, 620109
Turkey (Türkiye)7 sites
Novartis Investigative Site
Adana, Turkey, 01330
Novartis Investigative Site
Bursa, Turkey, 16059
Novartis Investigative Site
Gaziantep, Turkey, 27310
Novartis Investigative Site
Istanbul, Turkey, 35100
Novartis Investigative Site
Izmir, Turkey, 34890
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Talas / Kayseri, 38039
Canada6 sites
Novartis Investigative Site
Mirabel, Quebec, J7J 2K8
Novartis Investigative Site
Montreal, Quebec, H3G 1L5
Novartis Investigative Site
Niagara Falls, Ontario, L2G 1J4
Novartis Investigative Site
Québec, Quebec, GIV 4M6
Novartis Investigative Site
Trois-Rivières, Quebec, G8T 7A1
Novartis Investigative Site
Windsor, Ontario, N8X 5A6
Latvia6 sites
Novartis Investigative Site
Rēzekne, LV, LV-4600
Novartis Investigative Site
Riga, LV, 1002
Novartis Investigative Site
Riga, 1002
Novartis Investigative Site
Riga, LV-1004
Novartis Investigative Site
Riga, LV-1038
Novartis Investigative Site
Talsi, LV, LV3201
Lithuania5 sites
Novartis Investigative Site
Kaunas, LT, 44320
Novartis Investigative Site
Kaunas, 50009
Novartis Investigative Site
Klaipėda, LT, 92288
Novartis Investigative Site
Klaipėda, LT-92231
Novartis Investigative Site
Vilnius, LT-08661
Thailand4 sites
Novartis Investigative Site
Muang, Thailand, 11000
Novartis Investigative Site
Muang, Thailand, 30000
Novartis Investigative Site
Rajathevee, Thailand, 10400
Novartis Investigative Site
Ratchathewi, Thailand, 10400
Estonia3 sites
Novartis Investigative Site
Kohtla-Järve, Estonia, 30321
Novartis Investigative Site
Tallinn, Estonia, 10138
Novartis Investigative Site
Tartu, Estonia, 51014
Malaysia3 sites
Novartis Investigative Site
Kota Kinabalu, Malaysia, 88586
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Kuching, Sarawak, 93586
Belgium2 sites
Novartis Investigative Site
Kortrijk, Belgium, 8500
Novartis Investigative Site
Liège, Belgium, 4000
About this study
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
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.
- Conditions
- Asthma
- Being tested
- Mometasone furoate, Concept 1, Twisthaler
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoateDrug
Also called QMF149
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
Concept 1Device
A single dose dry powder inhaler (SDDPI)
TwisthalerDevice
A single dose dry powder inhaler (SDDPI)
| Study group | Role | What they receive |
|---|---|---|
| Mometasone furoate 80 μg | Experimental | 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. Receives: Drug: Mometasone furoate; Device: Concept 1 |
| Mometasone furoate 200 µg | Experimental | 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. Receives: Drug: Mometasone furoate; Device: Twisthaler |
| Mometasone furoate 320 µg | Experimental | 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. Receives: Drug: Mometasone furoate; Device: Concept 1 |
| Mometasone furoate 800 µg | Experimental | 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. Receives: Drug: Mometasone furoate; Device: Twisthaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 29
Secondary outcomes (10)
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.
Measured: Days 8, 15 and 22
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.
Measured: Days 1, 8, 15, 22, 28 and 29 at all time points
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.
Measured: Days 1, 8, 15, 22, 28 and 29 at all time points
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.
Measured: Days 1, 8, 15, 22, 28 and 29 at all time points
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.
Measured: Baseline and week 4
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).
Measured: Baseline, days 8,15,22 and 29
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.
Measured: Baseline and 4 weeks
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.
Measured: 4 weeks
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.
Measured: Days 15 and 29
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
Measured: Baseline, days 1 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555151
- Sponsor's protocol ID
- CQMF149E2201
- Other IDs
- 2011-005100-14
- Status last verified
- Apr 2015
- First submitted
- 13 Mar 2012
- Last updated
- 1 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01555151
- Acronym / sponsor ID
- CQMF149E2201
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 1 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mometasone furoate 80 μg | Experimental | Drug: Mometasone furoate, Device: Concept 1Description: 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 200 µg | Experimental | Drug: Mometasone furoate, Device: TwisthalerMometasone 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 320 µg | Experimental | Drug: Mometasone furoate, Device: Concept 1Mometasone 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 800 µg | Experimental | Drug: Mometasone furoate, Device: TwisthalerMometasone 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone furoateAlso: QMF149Mometasone 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 | Drug | Mometasone furoate 200 µg, Mometasone furoate 320 µg, Mometasone furoate 80 μg, Mometasone furoate 800 µg |
| Concept 1A single dose dry powder inhaler (SDDPI) | Device | Mometasone furoate 320 µg, Mometasone furoate 80 μg |
| TwisthalerA single dose dry powder inhaler (SDDPI) | Device | Mometasone furoate 200 µg, Mometasone furoate 800 µg |
Primary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 29
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.
10 secondary outcomes
Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment
Time frame: Days 8, 15 and 22
Forced Vital Capacity (FVC) at All Time Points
Time frame: Days 1, 8, 15, 22, 28 and 29 at all time points
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
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
Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment
Time frame: Baseline and week 4
Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit
Time frame: Baseline, days 8,15,22 and 29
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment
Time frame: Baseline and 4 weeks
Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment
Time frame: 4 weeks
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Days 15 and 29
Plasma Cortisol Concentrations
Time frame: Baseline, days 1 and 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
165 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mometasone furoate, Concept 1 and Twisthaler in people with Asthma, run by Novartis Pharmaceuticals at 165 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 165 sites in Hungary, Japan, Germany, Slovakia, India and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough Forced Expiratory Volume in 1 Second (FEV1) (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.