Clinical Trial Details

NCT ID: NCT02892344
Date Last Changed: June 13, 2017

Overview

Research Study Summary

A Phase 3 clinical study for patients with Mild Asthma

Research Study Title

A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
12 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Novartis Pharmaceuticals
Duration
99 Months
Facility Type
N/A
Compensation

Eligibility

All ages 12 Years to 75 Years

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: Exacerbation requiring systemic steroids, hospitalization ( > 24 hours) or emergency room visit (≤24 hours) within 6 months, prior to visit 1.

  • 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.

Site Locations (47)

Country State City Zip Facility and Contact
Estonia Kohtla-Jarve 30322 Novartis Investigative Site
Estonia Tallinn 10138 Novartis Investigative Site
Estonia Tallinn 13419 Novartis Investigative Site
Estonia Tallinn 13619 Novartis Investigative Site
Estonia Tartu 51014 Novartis Investigative Site
Germany Berlin 10119 Novartis Investigative Site
Germany Darmstadt 64283 Novartis Investigative Site
Germany Frankfurt 60596 Novartis Investigative Site
Germany Hamburg 20354 Novartis Investigative Site
Germany Hannover 30173 Novartis Investigative Site
Germany Landsberg 86899 Novartis Investigative Site
Germany Leipzig 04207 Novartis Investigative Site
Germany Lubeck 23552 Novartis Investigative Site
Germany Marburg D-35037 Novartis Investigative Site
Hungary HUN Gyor 9024 Novartis Investigative Site
Hungary HUN Szazhalombatta 2440 Novartis Investigative Site
Hungary Godollo 2100 Novartis Investigative Site
Hungary Szarvas 5540 Novartis Investigative Site
Hungary Szeged 6720 Novartis Investigative Site
Hungary Szeged 6722 Novartis Investigative Site
Italy Verona 37134 Novartis Investigative Site
Japan Tokyo Chuo-ku 103-0027 Novartis Investigative Site
Japan Tokyo Setagaya-ku 157006 Novartis Investigative Site
Japan Tokyo Shinjuku-ku 162-0053 Novartis Investigative Site
Japan Tokyo Toshima-ku 171-0014 Novartis Investigative Site
Korea, Republic of Gyeonggi do Anyang si 14068 Novartis Investigative Site
Korea, Republic of Seoul 02841 Novartis Investigative Site
Korea, Republic of Seoul 06591 Novartis Investigative Site
Latvia LV Riga 1011 Novartis Investigative Site
Latvia Daugavpils LV-5417 Novartis Investigative Site
Latvia Riga LV-1001 Novartis Investigative Site
Russian Federation Ekaterinburg 620028 Novartis Investigative Site
Russian Federation Moscow 115478 Novartis Investigative Site
Russian Federation St. Petersburg 191015 Novartis Investigative Site
Russian Federation St.-Petersburg 194044 Novartis Investigative Site
Russian Federation St.Petersburg 196240 Novartis Investigative Site
Slovakia Slovak Republic Bardejov 085 01 Novartis Investigative Site
Slovakia Slovak Republic Bojnice 972 01 Novartis Investigative Site
Slovakia Slovak Republic Liptovsky Hradok 033 01 Novartis Investigative Site
Slovakia Slovak Republic Spisska Nova Ves 052 01 Novartis Investigative Site
Slovakia SVK Banska Bystrica 974 05 Novartis Investigative Site
Slovakia SVK Poprad 058 01 Novartis Investigative Site
Slovakia Bratislava 841 04 Novartis Investigative Site
Slovakia Sabinov 08301 Novartis Investigative Site
Sweden Ostergotlands lan Linkoping 587 58 Novartis Investigative Site
Sweden Stockholm 111 57 Novartis Investigative Site
Sweden Uppsala 75237 Novartis Investigative Site

Contact

Novartis Pharmaceuticals
+41613241111
E-mail:

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