Bronchodilator effects and safety of glycopyrronium bromide (25 ug and 50 ug o.d.) in asthma

• Register: EUCTR
• Last refreshed on: 15 October 2018
• Main ID: EUCTR2015-005565-23-DE
• Date of registration: 28/02/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Bronchodilator effects and safety of glycopyrronium bromide (25 ug and 50 ug o.d.) in asthma
• Scientific title: A multicenter, randomized, double-blind, placebo-controlled 3-period complete cross-over study to assess the bronchodilator effects and safety of glycopyrronium bromide (NVA237) (25 µg and 50 µg o.d.) in asthma patients
• Date of first enrolment: 12/04/2017
• Target sample size: 144
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005565-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 6
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Germany, Japan, Latvia, Lithuania, United States

Contacts

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
? Male and female adult patients aged >= 18 or =< 65
years
? Patients with a diagnosis of asthma for a period of at least 1 year receiving daily treatment of ICS/LABA in a stable regimen for >= 4 weeks
? Pre-bronchodilator FEV1 of >= 50% and =< 80% of the predicted normal value and an increase in FEV1 of 12% and >= 200 ml during reversibility testing
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion criteria:
? Patients who have had an asthma exacerbation that required either treatment with systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment within 6 weeks prior to screening and patients with a history of life-threatening asthma attacks
? Patients who have had a respiratory tract infection within 4 weeks prior to screening.
? Patients who have smoked or inhaled tobacco products within the past 6 month of screening.
? Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease,
cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging).
? Patients on Maintenance Immunotherapy (desensitization) for allergies for at least 3 months prior to Run-in who are expected to change therapy throughout the course of the study.
? Patients who during the Run-in period are shown to be intolerable to LABA withdrawal.
? Patients who have discontinued LAMA therapy in the past (e.g. due to intolerance or perceived lack of efficacy).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Trade Name: Seebri Breezhaler
Product Name: Glycopyrronium bromide 44 µg (of active moiety delivered) or 50 µg(of active moiety in the capsule)
Product Code: NVA237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Current Sponsor code: NVA237
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Product Name: Glycopyrronium bromide 22 µg (of active moiety delivered) or 25µg (of active moiety in the capsule)
Product Code: NVA237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Current Sponsor code: NVA237
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Secondary Objective: To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo:
? In terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period
? In terms of Peak FEV1 following 1 week of treatment in the respective treatment period
? In terms of FEV1, FVC and FEV1/FVC ratio following 1 week of treatment in the respective treatment period
? In terms of Safety and tolerability in the respective treatment period (laboratory tests, vital signs, ECG and adverse events)
? As determined by patient diary data and electronic PEF meter in the respective treatment period.

Main Objective: To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared to placebo in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post -dose) following 1 week of treatment in the respective treatment period

Timepoint(s) of evaluation of this end point: Day 7

Primary end point(s): Trough FEV1 (mL) after 1 week of treatment defined as the mean of the two FEV1 values measured at 23 h 15 min and 23 h 45 min post-dose.

Secondary Outcome(s)

Secondary end point(s): • Standardized AUC in FEV1 across different time intervals (5 min – 1 h, 5 min – 4 h, 5 min – 23 h 45 min)
• Peak FEV1 during 5 min – 4 h.
• FVC and FEV1/FVC at day 7
• PEF pre-dose morning and evening
• Number of rescue puffs during the previous night and during the day

Timepoint(s) of evaluation of this end point: Day 7

Secondary ID(s)

CQVM149B2204

Source(s) of Monetary Support

Novartis Pharma AG