Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients

NCT02125734 | Completed Phase 4 Results

• 2 other identifiers: CQVA149ADE042013-004223-37
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 18

Brief Summary

The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation

  Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.

  week 4

Secondary Outcomes (2)

• Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.

  8 weeks

• Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.

  8 weeks

Study Arms (2)

Treatment sequence 1

EXPERIMENTAL

QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56

Drug: QVA149; Drug: Tiotropium

Treatment sequence 2

EXPERIMENTAL

Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56

Drug: QVA149; Drug: Tiotropium

Interventions

QVA149 DRUG

QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day

Also known as: indacaterol maleate/glycoporromium bromide

Treatment sequence 1; Treatment sequence 2

Tiotropium DRUG

Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day

Treatment sequence 1; Treatment sequence 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed an Informed Consent Form
• stable COPD according to current guidelines (GOLD 2013)
• airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of \<0.70 and a post-bronchodilator FEV1 of ≥30% and \<80% of predicted normal values at Visit 2.
• current or ex-smokers who have a smoking history of at least 10 pack years
• Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1
• Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).

You may not qualify if:

• Pregnant or breast feeding mothers
• Patients with conditions contraindicated for treatment
• Patients with a history of clinically significant diseases
• Patients who have a clinically significant renal disease
• Patients with myocardial infarctions less than 6 months prior to study entry
• Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.
• Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention
• Patients with a history of malignancy of any organ system
• Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening
• Patients who have had a respiratory tract infection within 6 weeks prior to Screening
• Patients with any history of asthma.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

Novartis Investigative Site

Ibbenbüren, Rhineland-Palatinate, 49477, Germany

Location

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Berlin, 13057, Germany

Location

Novartis Investigative Site

Bonn, 53119, Germany

Location

Novartis Investigative Site

Frankfurt, 60318, Germany

Location

Novartis Investigative Site

Frankfurt, 60389, Germany

Location

Novartis Investigative Site

Garmisch-Partenkirchen, 82467, Germany

Location

Novartis Investigative Site

Hanover, 30173, Germany

Location

Novartis Investigative Site

Kassel, 34121, Germany

Location

Novartis Investigative Site

Leipzig, 04275, Germany

Location

Novartis Investigative Site

München, 80686, Germany

Location

Novartis Investigative Site

Münster, 48147, Germany

Location

Novartis Investigative Site

Neu-Isenburg, 63263, Germany

Location

Novartis Investigative Site

Rheine, 48431, Germany

Location

Novartis Investigative Site

Siegen, 57072, Germany

Location

Novartis Investigative Site

Solingen, 42665, Germany

Location

Novartis Investigative Site

Sonneberg, 96515, Germany

Location

Novartis Investigative Site

Warendorf, 48231, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 12, 2017
• Results First Posted: January 20, 2016

Record last verified: 2017-03

Locations

DE (18)