NCT01287325

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 chronic-obstructive-pulmonary-disease

Geographic Reach
2 countries

2 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

September 1, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

7 months

First QC Date

January 26, 2011

Last Update Submit

January 28, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary diseaseCoughDNK333

Outcome Measures

Primary Outcomes (1)

  • Self-reported cough

    At 2 weeks

Secondary Outcomes (1)

  • Sensitivity to capsaicin challenge

    At 2 weeks

Study Arms (2)

DNK333

EXPERIMENTAL
Drug: DNK333 100 mg twice daily

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DNK333 100 mg twice dailyDRUG
DNK333
PlaceboDRUG
Placebo

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Zuidlaren, Netherlands

Location

Novartis Investigative Site

London, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCough

Interventions

DNK 333

Condition Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 26, 2011

First Posted

February 1, 2011

Study Start

September 1, 2003

Primary Completion

April 1, 2004

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

NL(1)GB(1)