NCT00274066

Brief Summary

To evaluate acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in comparison to placebo when given to COPD patients on pharmacodynamic steady state of tiotropium (Spiriva)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_3

Geographic Reach
1 country

5 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

October 1, 2002

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

11 months

First QC Date

January 9, 2006

Last Update Submit

October 31, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Peak FEV1 response, defined as the peak FEV1 minus the steady-state baseline FEV

    up to 37 days

Secondary Outcomes (9)

  • Peak FVC response in the six-hour observation period following administration of the first single dose of randomised treatment

    up to 37 days

  • FEV1 and FVC response one hour after the second dose of randomised treatment

    up to 37 days

  • Individual FEV1 and FVC measurements at each time point

    up to 37 days

  • sGaw and Raw measured at 1 and 6 hour after the first dose of randomised treatment and at 1 hour after the second dose of randomised treatment

    up to 37 days

  • All adverse events

    up to 37 days

  • +4 more secondary outcomes

Interventions

Tiotropium + placeboDRUG
Tiotropium + ipratropiumDRUG
Tiotropium + fenoterolDRUG

Eligibility Criteria

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

You may qualify if:

  • diagnosis of COPD
  • FEV1 \< 60% of predicted
  • FEV1 \< 70% of FVC
  • smoking history of 10 pack-years

You may not qualify if:

  • significant other disease than COPD
  • history of asthma, allergic rhinitis or blood eosinophil count \> 600mm3
  • cardiac arrhythmia requiring drug therapy
  • symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
  • recent history of MI (within past year)
  • history of cancer within past 5 years
  • life-threatening pulmonary obstruction
  • cystic fibrosis or bronchiectasis; tuberculosis
  • pulmonary resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Twenteborg Ziekenhuis

Almelo, 7609 PP, Netherlands

Location

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Boehringer Ingelheim Investigational Site

Groningen, 9700 RB, Netherlands

Location

Afdeling longziekten

Winschoten, 9670 RA, Netherlands

Location

Gelre Ziekenhuizen

Zutphen, 7207 BA, Netherlands

Location

Related Publications (1)

  • Kerstjens HA, Bantje TA, Luursema PB, Sinninghe Damste HE, de Jong JW, Lee A, Wijker SP, Cornelissen PJ. Effects of short-acting bronchodilators added to maintenance tiotropium therapy. Chest. 2007 Nov;132(5):1493-9. doi: 10.1378/chest.06-3059. Epub 2007 Sep 21.

    PMID: 17890476DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium BromideIpratropiumFenoterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingAtropine DerivativesBelladonna AlkaloidsSolanaceous AlkaloidsMetaproterenolEthanolaminesAmino AlcoholsAlcoholsAminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim BV/Alkmaar

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

October 1, 2002

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

NL(5)