Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01613326 | Completed Phase 3 Results

• 2 other identifiers: CNVA237A23142011-000960-93
• Study Type: interventional
• Target: 657
• Locations: 15 countries
• Sites: 77

Brief Summary

This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis)

  Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23hours 15min and 23 hours 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.

  Week 12

Secondary Outcomes (12)

• Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Analysis of Superiority)

  Week 12

• Transition Dyspnea Index (TDI) Focal Score After 4 Weeks and 12 Weeks of Treatment

  Weeks 4 and 12

• St. George's Respiratory Questionnaire Total Score After 12 Weeks of Treatment

  Week 12

• Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 12 Week Treatment

  Baseline and Day 1 to Week 12

• Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 4

  Day 1 and Week 4

Study Arms (2)

NVA237

EXPERIMENTAL

NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.

Drug: NVA237; Drug: Placebo to tiotropium; Drug: salbutamol/albuterol

Tiotropium

ACTIVE COMPARATOR

Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.

Drug: Tiotropium; Drug: Placebo to NVA237

Interventions

NVA237 DRUG

NVA237 50 μg inhalation capsules once a day, delivered via SDDPI

NVA237

Tiotropium DRUG

Tiotropium 18 μg once a day delivered via HandiHaler® device

Tiotropium

Placebo to tiotropium DRUG

Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device.

NVA237

Placebo to NVA237 DRUG

Placebo to NVA237 50 μg once a day delivered via SDDPI

Tiotropium

salbutamol/albuterol DRUG

salbutamol/albuterol given as a rescue medication via inhaler when needed

NVA237

Eligibility Criteria

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

You may qualify if:

• Patients with moderate to severe stable COPD (Stage II or Stage III) according to the current GOLD Guidelines (GOLD 2010).
• Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥ 30% and \< 80% of the predicted normal, and a post-bronchodilator FEV1/ Forced Vital Capacity (FVC) \< 0.70 at screening
• 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).
• Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.

You may not qualify if:

• Pregnant or nursing (lactating) women
• Patients who, in the judgment of the investigator, or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition before Visit 1.
• Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (BPH patients who are stable on treatment can be considered).
• Patients receiving medications in the classes listed in the protocol as prohibited.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (77)

Novartis Investigative Site

Toronto, Ontario, M5G1N8, Canada

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Novartis Investigative Site

Toronto, Ontario, M5T 3A9, Canada

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Toronto, Ontario, M6H 3M2, Canada

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Gatineau, Quebec, J8Y 6S8, Canada

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Novartis Investigative Site

Mirabel, Quebec, J7J 2K8, Canada

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Novartis Investigative Site

Saint-Charles-Borromée, Quebec, J6E 6J2, Canada

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Novartis Investigative Site

Sisak, Croatia, 44000, Croatia

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Novartis Investigative Site

Zagreb, Croatia, 10 000, Croatia

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Novartis Investigative Site

Zagreb, 10000, Croatia

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Novartis Investigative Site

Cvikov, Czech Republic, 471 54, Czechia

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Novartis Investigative Site

Liberec, Czech Republic, 460 01, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 108 00, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 140 46, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 169 00, Czechia

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Novartis Investigative Site

Rudná, Czech Republic, 25219, Czechia

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Novartis Investigative Site

Teplice, Czech Republic, 415 01, Czechia

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Novartis Investigative Site

Žatec, Czech Republic, 438 01, Czechia

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Novartis Investigative Site

Tartu, Estonia, 51014, Estonia

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Novartis Investigative Site

Paide, 72714, Estonia

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Novartis Investigative Site

Tallinn, 13419, Estonia

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Novartis Investigative Site

Tallinn, 13619, Estonia

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Novartis Investigative Site

Beuvry, France, 62660, France

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Novartis Investigative Site

Lyon, 69317, France

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Novartis Investigative Site

Nantes, 44000, France

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Novartis Investigative Site

Reims, 51092, France

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Novartis Investigative Site

Berlin, Germany, 10117, Germany

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Novartis Investigative Site

Berlin, Germany, 14050, Germany

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Novartis Investigative Site

Leipzig, Germany, 04207, Germany

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Novartis Investigative Site

Wiesbaden, Germany, 65187, Germany

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Novartis Investigative Site

Berlin, 14050, Germany

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Frankfurt, 60596, Germany

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Hamburg, 20253, Germany

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Novartis Investigative Site

Kassel, 34121, Germany

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Novartis Investigative Site

Potsdam, 14478, Germany

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Novartis Investigative Site

Rüdersdorf, 15562, Germany

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Novartis Investigative Site

Guatemala City, Departamento de Guatemala, 01010, Guatemala

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Novartis Investigative Site

Guatemala City, Departamento de Guatemala, 01011, Guatemala

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Novartis Investigative Site

Guntur, Andhra Pradesh, 522 001, India

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Novartis Investigative Site

Ahmedabad, Gujarat, 380 009, India

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Novartis Investigative Site

Chennai - Tamil Nadu, India, 600 087, India

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Novartis Investigative Site

Bangalore, Karnataka, 560 010, India

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Novartis Investigative Site

Nagpur, Maharashtra, India

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Novartis Investigative Site

Coimbatore, Tamil Nadu, 641 045, India

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Novartis Investigative Site

Coimbatore, Tamil Nadu, 641014, India

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Novartis Investigative Site

Daugavpils, LV-5401, Latvia

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Novartis Investigative Site

Riga, 1002, Latvia

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Novartis Investigative Site

Alytus, LT-62114, Lithuania

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Novartis Investigative Site

Kaunas, LT-47144, Lithuania

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Novartis Investigative Site

Klaipėda, 92288, Lithuania

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Novartis Investigative Site

Klaipėda, LT-92231, Lithuania

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Novartis Investigative Site

Utena, LT-28151, Lithuania

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Novartis Investigative Site

Vilnius, 06001, Lithuania

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Novartis Investigative Site

Vilnius, LT-08661, Lithuania

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Novartis Investigative Site

Lipa City, Batangas, 4217, Philippines

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Novartis Investigative Site

Bulacan, Philippines, 3020, Philippines

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Novartis Investigative Site

Manila, Philippines, 1000, Philippines

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Novartis Investigative Site

Quezon City, 1100, Philippines

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Novartis Investigative Site

Gdansk, 80-169, Poland

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Novartis Investigative Site

Gdansk, 80-847, Poland

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Novartis Investigative Site

Katowice, 40-752, Poland

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Novartis Investigative Site

Poznan, 60-693, Poland

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Novartis Investigative Site

Wroclaw, 51-162, Poland

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Novartis Investigative Site

Cape Town, 7500, South Africa

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Novartis Investigative Site

Cape Town, 7925, South Africa

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Novartis Investigative Site

Gatesville, 7764, South Africa

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Novartis Investigative Site

Busan, Busan, 602-739, South Korea

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Novartis Investigative Site

Bucheon-si, Gyeonggi-do, South Korea

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Novartis Investigative Site

Seoul, Seoul, 130-709, South Korea

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Novartis Investigative Site

Seoul, Seoul, 156-755, South Korea

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Novartis Investigative Site

Daegu, 705-717, South Korea

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Novartis Investigative Site

Seoul, 130-702, South Korea

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Novartis Investigative Site

Seoul, 152-703, South Korea

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Novartis Investigative Site

Chiayi City, Taiwan, 600, Taiwan

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Novartis Investigative Site

Niaosong Township, Taiwan, 83301, Taiwan

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Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

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Novartis Investigative Site

Taipei County, Taiwan, Taiwan

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Novartis Investigative Site

Chiayi City, Taiwan

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Related Publications (1)

• Chapman KR, Beeh KM, Beier J, Bateman ED, D'Urzo A, Nutbrown R, Henley M, Chen H, Overend T, D'Andrea P. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med. 2014 Jan 17;14:4. doi: 10.1186/1471-2466-14-4.

  PMID: 24438744 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; Tiotropium Bromide; Albuterol

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)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

4 161 324 1111

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: June 7, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 23, 2014
• Results First Posted: April 23, 2014

Record last verified: 2014-04

Locations

TW (5); CR (3); CA (6); ZA (3); LA (2); IN (7); PL (5); DE (10); KR (7); LI (7); GU (2); ES (4); PH (4); CZ (8); FR (4)