NCT00628862

Brief Summary

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
613

participants targeted

Target at P50-P75 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Dec 2007

Geographic Reach
5 countries

47 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

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

October 25, 2012

Completed
Last Updated

October 25, 2012

Status Verified

September 1, 2012

Enrollment Period

1.3 years

First QC Date

January 24, 2008

Results QC Date

March 19, 2010

Last Update Submit

September 25, 2012

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose

    FEV1 (expressed as litres \[L\]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.

    from baseline up to 12 weeks

Secondary Outcomes (12)

  • Forced Vital Capacity (FVC) 60 Minutes Post-dose

    from baseline up to 12 weeks

  • FEV1 Pre-dose

    baseline at week 0 and pre-dose at weeks 4, 8 and 12

  • FVC Pre-dose

    baseline at week 0 and pre-dose at weeks 4, 8 and 12

  • FEV1 5 Minutes Post-dose

    baseline and 5 minutes anter first dose

  • FVC 5 Minutes Post-dose

    baseline and 5 minutes anter first dose

  • +7 more secondary outcomes

Study Arms (3)

F 4.5 bid

EXPERIMENTAL

Formoterol 4.5 ug twice daily (bid)

Drug: Formoterol Turbuhaler® 4.5mg

F 9.0 bid

EXPERIMENTAL

Formoterol 9.0 ug bid

Drug: Formoterol Turbuhaler® 9 mg

PBO

PLACEBO COMPARATOR

Placebo

Drug: Turbuhaler® placebo

Interventions

Formoterol Turbuhaler® 4.5mgDRUG

4.5 mg inhaled twice daily

Also known as: Oxis
F 4.5 bid
Formoterol Turbuhaler® 9 mgDRUG

9 mg inhaled twice daily

Also known as: Oxis
F 9.0 bid
Turbuhaler® placeboDRUG

placebo inhaled twice daily

PBO

Eligibility Criteria

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

You may qualify if:

  • Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
  • Current or previous smoker with a smoking history of 10 or more pack years
  • Lung function parameters: FEV1/FVC \< 70%, post-bronchodilator and post-bronchodilator FEV1 \< 80% of predicted normal value

You may not qualify if:

  • History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
  • Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
  • Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Research Site

Gabrovo, Bulgaria

Location

Research Site

Lovech, Bulgaria

Location

Research Site

Pleven, Bulgaria

Location

Research Site

Rousse, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Stara Zagora, Bulgaria

Location

Research Site

Troyan Municipality, Bulgaria

Location

Research Site

Varna, Bulgaria

Location

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Seto, Aichi-ken, Japan

Location

Research Site

Noda, Chiba, Japan

Location

Research Site

Touon, Ehime, Japan

Location

Research Site

Yanagawa, Fukuoka, Japan

Location

Research Site

Ōta, Gunma, Japan

Location

Research Site

Ōwa, Gunma, Japan

Location

Research Site

Hiroshima, Hiroshima, Japan

Location

Research Site

Asahikawa, Hokkaido, Japan

Location

Research Site

Chitose, Hokkaido, Japan

Location

Research Site

Obihiro, Hokkaido, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Tomakomai, Hokkaido, Japan

Location

Research Site

Yabu, Hyōgo, Japan

Location

Research Site

Naka-gun, Ibaraki, Japan

Location

Research Site

Morioka, Iwate, Japan

Location

Research Site

Kagoshima, Kagoshima-ken, Japan

Location

Research Site

Kawasaki, Kangawa, Japan

Location

Research Site

Kochi, Kochi, Japan

Location

Research Site

Kyoto, Kyoto, Japan

Location

Research Site

Sendai, Miyagi, Japan

Location

Research Site

Katano, Osaka, Japan

Location

Research Site

Kishiwada, Osaka, Japan

Location

Research Site

Osaka, Osaka, Japan

Location

Research Site

Takatsuiki, Osaka, Japan

Location

Research Site

Chiyoda City, Tokyo, Japan

Location

Research Site

Wakayama, Wakayama, Japan

Location

Research Site

Ube, Yamaguchi, Japan

Location

Research Site

Deva, Hunedoara County, Romania

Location

Research Site

Bucharest, Romania

Location

Research Site

Constanța, Romania

Location

Research Site

Iași, Romania

Location

Research Site

Kazan', Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Dnipropetrovsk, Ukraine

Location

Research Site

Donetsk, Ukraine

Location

Research Site

Kharkiv, Ukraine

Location

Research Site

Kyiv, Ukraine

Location

Related Publications (1)

  • Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 mug twice daily in Japanese and European COPD patients: phase III study results. BMC Pulm Med. 2011 Nov 15;11:51. doi: 10.1186/1471-2466-11-51.

    PMID: 22085439DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Lars-Goran Carlsson, MD

    AstraZeneca R&D Lund, Sweden

    STUDY DIRECTOR

  • Miron A Bogdan, MD

    Clinica Medic Or, Calea

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2008

First Posted

March 5, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

October 25, 2012

Results First Posted

October 25, 2012

Record last verified: 2012-09

Locations

BU(8)JP(28)UA(4)RO(4)RU(3)