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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02892344
Other study ID # CQVM149B2303
Secondary ID 2016-000472-22
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 1, 2017
Est. completion date November 23, 2018

Study information

Verified date October 2018
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email trialandresults.registries@novartis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the trial is to evaluate efficacy and safety of QMF149 150/80 microgram o.d.

delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study will assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.


Description:

The primary objective of this study is to demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. The key secondary objective of this study is to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date November 23, 2018
Est. primary completion date November 22, 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit

- Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit

- Adult patients who are symptomatic at screening despite treatment with existing therapy.

Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102 (inadequately controlled).

- Adolescent patients :

- If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score = 1.5 at Visit 101 and at Visit 102 .

- If taking ICS (low dose)/ LABA, and have ACQ-7 score =1 and <1.5 at Visit 101: they must have ACQ-7 score=1.5 at Visit 102 ( prior to randomization).

- Pre-bronchodilator FEV1= 60 % and < 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102

- Patients who demonstrate an increase in FEV1 of 12% and = 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.

Exclusion Criteria:

- Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.

- Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (= 24 hours) as follows:

- For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation

- For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR hospitalization (> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR emergency room visit (= 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months.

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

- Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment )

- Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.

- Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study.

- Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.

- Patients with Type I diabetes or uncontrolled Type II diabetes.

- Patients with narcolepsy and/or insomnia.

- Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.

- Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.

- Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
QMF149 150/80 µg
QMF149 150/80 µg o.d via Concept1
MF 200 µg
MF 200 µg o.d. via Twisthaler®

Locations

Country Name City State
Bulgaria Novartis Investigative Site Pleven
Bulgaria Novartis Investigative Site Stara Zagora
Chile Novartis Investigative Site Santiago Region Metropolitana
Chile Novartis Investigative Site Santiago
Chile Novartis Investigative Site Santiago
Chile Novartis Investigative Site Vina del Mar
Colombia Novartis Investigative Site Bogota Cundinamarca
Colombia Novartis Investigative Site Bogota
Colombia Novartis Investigative Site Bucaramanga
Colombia Novartis Investigative Site Medellin
Colombia Novartis Investigative Site Medellin Antioquia
Estonia Novartis Investigative Site Kohtla-Jarve
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tartu
Germany Novartis Investigative Site Bad Woerishofen
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Darmstadt
Germany Novartis Investigative Site Essen Rheinland Pfalz
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Gauting
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Landsberg
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Lubeck
Germany Novartis Investigative Site Mainz
Germany Novartis Investigative Site Marburg
Hungary Novartis Investigative Site Cegled
Hungary Novartis Investigative Site Godollo
Hungary Novartis Investigative Site Gyor HUN
Hungary Novartis Investigative Site Szarvas
Hungary Novartis Investigative Site Szazhalombatta HUN
Hungary Novartis Investigative Site Szeged
Hungary Novartis Investigative Site Szeged
Hungary Novartis Investigative Site Torokbalint Pest
India Novartis Investigative Site Ahmedabad Gujarat
India Novartis Investigative Site Ahmedabad Gujarat
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Bikaner Rajasthan
India Novartis Investigative Site Cherthala Kerala
India Novartis Investigative Site Coimbatore Tamil Nadu
India Novartis Investigative Site Hubli Karnataka
India Novartis Investigative Site Hyderabad Telangana
India Novartis Investigative Site Mumbai Maharashtra
India Novartis Investigative Site Mysore Karnataka
India Novartis Investigative Site Nagpur Maharashtra
India Novartis Investigative Site Vadodara Gujarat
India Novartis Investigative Site Varanasi Uttar Pradesh
Italy Novartis Investigative Site Cassano delle Murge BA
Italy Novartis Investigative Site Firenze FI
Italy Novartis Investigative Site Firenze FI
Italy Novartis Investigative Site Fiumicino RM
Italy Novartis Investigative Site Genova
Italy Novartis Investigative Site Roma
Italy Novartis Investigative Site Verona
Japan Novartis Investigative Site Chuo-ku Tokyo
Japan Novartis Investigative Site Chuo-ku Tokyo
Japan Novartis Investigative Site Setagaya-ku Tokyo
Japan Novartis Investigative Site Shinjuku-ku Tokyo
Japan Novartis Investigative Site Toshima-ku Tokyo
Korea, Republic of Novartis Investigative Site Anyang si Gyeonggi Do
Korea, Republic of Novartis Investigative Site Bucheon-Si Gyeonggi-Do
Korea, Republic of Novartis Investigative Site Busan
Korea, Republic of Novartis Investigative Site Hwaseong-si Gyeonggi-do
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul KOR
Korea, Republic of Novartis Investigative Site Seoul Seocho-gu
Korea, Republic of Novartis Investigative Site Suwon Gyeonggi-do
Latvia Novartis Investigative Site Daugavpils
Latvia Novartis Investigative Site Jurmala LVA
Latvia Novartis Investigative Site Riga LV
Latvia Novartis Investigative Site Riga
Latvia Novartis Investigative Site Riga
Latvia Novartis Investigative Site Riga
Latvia Novartis Investigative Site Riga
Lithuania Novartis Investigative Site Kaunas LTU
Lithuania Novartis Investigative Site Vilnius
Lithuania Novartis Investigative Site Vilnius
Lithuania Novartis Investigative Site Vilnius
Malaysia Novartis Investigative Site Alor Setar Kedah
Malaysia Novartis Investigative Site Kuala Terengganu Terengganu
Malaysia Novartis Investigative Site Putrajaya
Malaysia Novartis Investigative Site Taiping Perak
Peru Novartis Investigative Site Cusco
Peru Novartis Investigative Site Lima
Peru Novartis Investigative Site Lima
Peru Novartis Investigative Site Piura
Peru Novartis Investigative Site Santiago de Surco Lima
Philippines Novartis Investigative Site Iloilo city Iloilo
Philippines Novartis Investigative Site Manila
Philippines Novartis Investigative Site Quezon City
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Biaystok
Poland Novartis Investigative Site Grudziadz
Poland Novartis Investigative Site Katowice
Russian Federation Novartis Investigative Site Ekaterinburg
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Rostov-on-Don
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site St Petersburg
Russian Federation Novartis Investigative Site St.Petersburg
Slovakia Novartis Investigative Site Banska Bystrica SVK
Slovakia Novartis Investigative Site Bardejov Slovak Republic
Slovakia Novartis Investigative Site Bojnice Slovak Republic
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Cadca
Slovakia Novartis Investigative Site Humenne Slovak Republic
Slovakia Novartis Investigative Site Liptovsky Hradok Slovak Republic
Slovakia Novartis Investigative Site Poprad SVK
Slovakia Novartis Investigative Site Presov
Slovakia Novartis Investigative Site Sabinov
Slovakia Novartis Investigative Site Spisska Nova Ves Slovak Republic
Slovakia Novartis Investigative Site Stropkov Slovak Republic
Slovakia Novartis Investigative Site Zvolen
South Africa Novartis Investigative Site Belleville
South Africa Novartis Investigative Site Brandfort Free State
South Africa Novartis Investigative Site Cape Town ZAF
South Africa Novartis Investigative Site Cape Town
South Africa Novartis Investigative Site Centurion ZAF
South Africa Novartis Investigative Site Middelburg Mpumalanga
South Africa Novartis Investigative Site Panorama
Sweden Novartis Investigative Site Linkoping Ostergotlands Lan
Sweden Novartis Investigative Site Stockholm
Sweden Novartis Investigative Site Uppsala
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Chiang Mai
Thailand Novartis Investigative Site Khon Kaen THA
Vietnam Novartis Investigative Site Hai Phong
Vietnam Novartis Investigative Site Ho Chi Minh VNM

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Bulgaria,  Chile,  Colombia,  Estonia,  Germany,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Peru,  Philippines,  Poland,  Russian Federation,  Slovakia,  South Africa,  Sweden,  Thailand,  Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary trough FEV1 demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents.
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
week 12
Secondary ACQ-7 ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control week 12
Secondary trough FEV1 at day 2 Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing week 12
Secondary Pre-dose FEV1 at week 4 Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose week 12
Secondary FVC over 12 weeks FVC is the total amount of air exhaled during the FEV test. Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) will be measured week 12
Secondary PEF over 4 and 12 weeks Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration week 12
Secondary Percentage of patients with MID at week 12 MID is Minimum Important Difference. ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) will be measured. week 12
Secondary Daily e-diary over 12 weeks Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded by daily electronic Diary (e-Diary) over 12 weeks of treatment week 12
Secondary ACQ-7 at week 4 ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control week 12
Secondary Rescue medication use over 12 weeks Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment week 12
Secondary Percentage of rescue medication free days over 12 weeks Percentage of rescue medication free days over 12 weeks of treatment period week 12
Secondary Asthma exacerbation over 12 weeks The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe. Time to first asthma exacerbation by exacerbation category. Annual rate of asthma exacerbations by exacerbation category. week 12
Secondary Quality of life assessed by AQLQ-S 12 Asthma Quality of Life questionnaire week 12
Secondary Composite endpoint of serious asthma outcomes Cumulative incidence of the composite endpoint of serious asthma outcomes (ie asthma related hospitalization, asthma-related intubation, or asthma-related death) over 12 weeks of treatment week 12
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