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

NCT ID: NCT01922271

Last Updated: 2015-01-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NVA237 followed by tiotropium

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.

Group Type EXPERIMENTAL

NVA237

Intervention Type DRUG

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

Tiotropium

Intervention Type DRUG

Tiotropium 18 μg once daily delivered via HandiHaler® device.

Placebo to tiotropium

Intervention Type DRUG

Placebo to tiotropium once daily delivered via HandiHaler® device

Salbutamol

Intervention Type DRUG

Used as resuce medication

Tiotropium followed by NVA237

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.

Group Type EXPERIMENTAL

Placebo to NVA237

Intervention Type DRUG

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

Salbutamol

Intervention Type DRUG

Used as resuce medication

Interventions

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NVA237

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

Intervention Type DRUG

Tiotropium

Tiotropium 18 μg once daily delivered via HandiHaler® device.

Intervention Type DRUG

Placebo to NVA237

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

Intervention Type DRUG

Placebo to tiotropium

Placebo to tiotropium once daily delivered via HandiHaler® device

Intervention Type DRUG

Salbutamol

Used as resuce medication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Leipzig, Germany, Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Gelsenkirchen, , Germany

Site Status

Novartis Investigative Site

Großhansdorf, , Germany

Site Status

Novartis Investigative Site

Gummersbach, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Kassel, , Germany

Site Status

Novartis Investigative Site

Lübeck, , Germany

Site Status

Novartis Investigative Site

Rüdersdorf, , Germany

Site Status

Novartis Investigative Site

Sonneberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 27940287 (View on PubMed)

Other Identifiers

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CNVA237ADE02

Identifier Type: -

Identifier Source: org_study_id

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