NCT01922271

Brief Summary

The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 1, 2015

Completed
Last Updated

January 1, 2015

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

August 9, 2013

Results QC Date

December 19, 2014

Last Update Submit

December 19, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2

    Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).

    Day 1

Secondary Outcomes (6)

  • Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose

    Day 1

  • Specific Airway Resistance (sRAW)

    Day 1

  • Functional Resistance Capacity (FRCpleth)

    Day 1

  • Residual Volume (RV)

    Day 1

  • Total Lung Capacity (TLC)

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

NVA237 followed by tiotropium

EXPERIMENTAL

Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.

Drug: NVA237Drug: TiotropiumDrug: Placebo to tiotropiumDrug: Salbutamol

Tiotropium followed by NVA237

EXPERIMENTAL

Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.

Drug: Placebo to NVA237Drug: Salbutamol

Interventions

NVA237DRUG

NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)

NVA237 followed by tiotropium
TiotropiumDRUG

Tiotropium 18 μg once daily delivered via HandiHaler® device.

NVA237 followed by tiotropium
Placebo to NVA237DRUG

Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).

Tiotropium followed by NVA237
Placebo to tiotropiumDRUG

Placebo to tiotropium once daily delivered via HandiHaler® device

NVA237 followed by tiotropium
SalbutamolDRUG

Used as resuce medication

NVA237 followed by tiotropiumTiotropium followed by NVA237

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults aged ≥40 years
  • Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of \<0.70 and a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.
  • Current or ex-smokers who have a smoking history of at least 10 pack years.

You may not qualify if:

  • Pregnant or nursing (lactating) women
  • Patients who have a clinically significant laboratory abnormality at run-in
  • Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR \<50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
  • Patients with any history of asthma
  • Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
  • Patients receiving medications in the classes listed in the protocol as prohibited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Novartis Investigative Site

Leipzig, Germany, 04207, Germany

Location

Novartis Investigative Site

Berlin, 12043, Germany

Location

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Berlin, 12687, Germany

Location

Novartis Investigative Site

Berlin, 13086, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Gelsenkirchen, 45879, Germany

Location

Novartis Investigative Site

Großhansdorf, 22947, Germany

Location

Novartis Investigative Site

Gummersbach, 51643, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Kassel, 34121, Germany

Location

Novartis Investigative Site

Lübeck, 23552, Germany

Location

Novartis Investigative Site

Rüdersdorf, 15562, Germany

Location

Novartis Investigative Site

Sonneberg, 96515, Germany

Location

Related Publications (1)

  • Watz H, Mailander C, May C, Baier M, Kirsten AM. Fast onset of action of glycopyrronium compared with tiotropium in patients with moderate to severe COPD - A randomised, multicentre, crossover trial. Pulm Pharmacol Ther. 2017 Feb;42:13-20. doi: 10.1016/j.pupt.2016.12.001. Epub 2016 Dec 9.

    PMID: 27940287DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GlycopyrrolateTiotropium BromideAlbuterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingEthanolaminesAmino AlcoholsAlcoholsPhenethylaminesEthylamines

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
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 14, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 1, 2015

Results First Posted

January 1, 2015

Record last verified: 2014-12

Locations

DE(14)