Efficacy of DNK333 in Patients With COPD and Cough

NCT ID: NCT01287325

Last Updated: 2011-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Brief Summary

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This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients with COPD and cough.

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

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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DNK333

Group Type EXPERIMENTAL

DNK333 100 mg twice daily

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DNK333 100 mg twice daily

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate COPD
* Forced expiratory volume in 1 second (FEV1) ≥30% predicted
* FEV1/FVC (forced vital capacity) \<70%
* Significant amount of cough and minimal amount of sputum production, both as judged by self reporting

Exclusion Criteria

* Upper or lower airway infection within 4 weeks prior to screening
* COPD exacerbation within 4 weeks prior to screening
* Past history or current diagnosis of congestive heart failure, cirrhosis or hepatic failure
* History of lung cancer or pulmonary resection/thoracic radiotherapy
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Zuidlaren, , Netherlands

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

Other Identifiers

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DNK333C2201

Identifier Type: -

Identifier Source: org_study_id

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