Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With COPD.

NCT01996319 | Completed Phase 3 Results

• 1 other identifier: CQVA149ADE03
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 30

Brief Summary

This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; COPD

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo

  Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36

  Baseline, day 22, baseline day 36, day 57

• Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level

  Average physical activity level is defined by average daily activity-related energy consumption \[Kcal/day\], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36

  Baseline, day 22, baseline day 36, day 57

Secondary Outcomes (6)

• Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day

  Baseline, day 22, baseline day 36, day 57

• Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo

  Baseline, day 22, baseline day 36, day 57

• Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.

  Day 1 or day 36

• Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo

  Baseline, day 22, baseline day 36, day 57

• Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1

  Day 1 or day 36

Study Arms (2)

Treatment sequence I

ACTIVE COMPARATOR

QVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days

Drug: QVA149; Drug: Placebo

Treatment sequence II

ACTIVE COMPARATOR

Placebo once a day during 21 days cross-over to QVA149 once a day for 21 days

Drug: QVA149; Drug: Placebo

Interventions

QVA149 DRUG

QVA149 (110/50 µg) once a day via Breezhaler® device

Treatment sequence I; Treatment sequence II

Placebo DRUG

Placebo once a day via Breezhaler® device

Treatment sequence I; Treatment sequence II

Eligibility Criteria

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

You may qualify if:

• Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs)..
• Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and \<80% of the predicted normal, and a post-bronchodilator FEV1/FVC \<0.70

You may not qualify if:

• Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study.
• Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
• Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.
• Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
• Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.
• Patients who have had a respiratory tract infection within 4 weeks prior to screening.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (30)

Novartis Investigative Site

Heidelberg, Germany, 69117, Germany

Location

Novartis Investigative Site

Potsdam, Germany, 14467, Germany

Location

Novartis Investigative Site

Teterow, Germany, 17166, Germany

Location

Novartis Investigative Site

Koblenz, North Rhine-Westphalia, 56068, Germany

Location

Novartis Investigative Site

Cottbus, Saxony, 03050, Germany

Location

Novartis Investigative Site

Geesthacht, Schleswig-Holstein, 12502, Germany

Location

Novartis Investigative Site

Berlin, State of Berlin, 10119, Germany

Location

Novartis Investigative Site

Aschaffenburg, 63739, Germany

Location

Novartis Investigative Site

Berlin, 10629, Germany

Location

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Cologne, 51605, Germany

Location

Novartis Investigative Site

Düren, 52349, Germany

Location

Novartis Investigative Site

Erlangen, 91052, Germany

Location

Novartis Investigative Site

Euskirchen, 53879, Germany

Location

Novartis Investigative Site

Großhansdorf, 22947, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Höchstadt an der Aisch, 91315, Germany

Location

Novartis Investigative Site

Kassel, 34121, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Leipzig, 04207, Germany

Location

Novartis Investigative Site

Lübeck, 23552, Germany

Location

Novartis Investigative Site

Lübeck, 23558, Germany

Location

Novartis Investigative Site

Marburg, 35037, Germany

Location

Novartis Investigative Site

Münster, 48145, Germany

Location

Novartis Investigative Site

Neunkirchen, 66539, Germany

Location

Novartis Investigative Site

Potsdam, 14469, Germany

Location

Novartis Investigative Site

Rheine, 48431, Germany

Location

Novartis Investigative Site

Rüdersdorf, 15562, Germany

Location

Novartis Investigative Site

Saarbrücken, 66111, Germany

Location

Novartis Investigative Site

Wiesloch, 69168, Germany

Location

Related Publications (1)

• Watz H, Mailander C, Baier M, Kirsten A. Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo-controlled, crossover study (The MOVE Study). BMC Pulm Med. 2016 Jun 14;16(1):95. doi: 10.1186/s12890-016-0256-7.

  PMID: 27301417 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination

Condition Hierarchy (Ancestors)

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

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 27, 2013
• Study Start: April 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 5, 2016
• Results First Posted: April 5, 2016

Record last verified: 2016-03

Locations

DE (30)