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A randomized, double-blind, parallel group, 52-week study evaluating the efficacy, safety and tolerability of NVA237 in patients with poorly controlled asthma (CNVA237B2301)

A randomized, double-blind, parallel group, 52-week study evaluating the efficacy, safety and tolerability of NVA237 in patients with poorly controlled asthma (CNVA237B2301) - CNVA237B2301

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41186
Enrollment
30
Registered
2014-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchial asthma

Interventions

Treatment with NVA237 or placebo.

Sponsors

Novartis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male and female adult patients aged 18-75 years. * Diagnosis of asthma (according to GINA 2012) for a period of at least 5 years prior screening and prior to the age of 40. * Increase in FEV1 of * 12% and * 200 mLs within 30 minutes after administration of 400 *g salbutamol (or equivalent dose). * Pre-bronchodilator FEV1 of * 50 and * 80% of predicted. * Stable dose of a fixed dose ICS and LABA combination for at least 4 weeks prior to screening. Total daily dose of ICS of * 800 *g/day of budesonide or equivalent. * Symptomatic with a mean ACQ-5 score * 1.5 at Visit 101 and Visit 102. * A documented history of one or more asthma exacerbations in the previous 12 months. See protocol page 22 for details.

Exclusion criteria

Exclusion criteria: * ECG abnormalities. See protocol page 23 for details. * Prohibited medications. See protocol page 30-31 for details. * Pregnancy, lactation. * Females of childbearing potential not using adequate contraception. See protocol page 23 for details. * Type 1 or 2 uncontrolled diabetes. * BMI of more than 40 kg/m2. * Asthma exacerbation in the 6 weeks prior to screening. See protocol page 24 items 13-14 for details. * Respiratory tract infection in the 4 weeks prior to screening. See protocol page 24 items 15-16 for details. * Smoking in the past 6 months or smoking history of more than 10 pack years.

Design outcomes

Primary

MeasureTime frame
Through level FEV1 after 26 weeks of treatment.—

Secondary

MeasureTime frame
Time to 1st moderate to severe asthma exacerbation *definition see protocol page 50), ACQ-7 at week 26. At week 52: St George questionnaire, asthma quality of life questionnaire, ACQ-7, 6, 5, trough FEV1 and other pulmonary function parameters. Throughout the study: pulmonary function parameters, peakflow at home, asthma symptoms, rescue medication use, safety and tolerability.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)