Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease

October 24, 2011 updated by: Novartis Pharmaceuticals

Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease

This study is not being conducted in the United States.

This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

847

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Co-operative males or females with a diagnosis of moderate COPD as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria with an age at onset ≥ 40 years.
  • Current or previous smokers with a smoking history of ≥ 10 pack-years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
  • Pre-bronchodilator forced expiratory volume in one second (FEV1) < 70% of patient's predicted normal value and ≥ 1.00 L, with FEV1/forced vital capacity (FVC) < 70% at Visit 2.
  • A total symptom score from the patient diary of more than 0 on at least 4 of the last 7 days prior to Visit 3

Exclusion Criteria:

  • Pregnant women, nursing mothers, and females of childbearing potential, regardless of whether or not sexually active, who do not use a reliable contraceptive method (oral, mechanical, subcutaneous or surgical contraception).
  • Patients who have been hospitalized for an acute exacerbation of their airway diseases in the month prior to Visit 1 or during screening.
  • Patients who have had a respiratory tract infection within 1 month prior to Visit 1. Patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 1 month after the resolution of the respiratory tract infection).
  • Patients with concomitant pulmonary disease including a history of cancer (all), pulmonary tuberculosis or congenital bronchiectasis.
  • History of asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment

Secondary Outcome Measures

Outcome Measure
Forced Expiratory Volume in 1 second measured pre-dose, 5 minutes, 2 h and 3 h post dose at day 1, week 12 and week 24
Forced Vital Capacity measured pre-dose, 5 minutes, 2 h and 3 h post dose at day 1, week 12 and week 24
St. George's Respiratory Questionnaire following 12 and 24 weeks of treatment.
COPD "Bad Days" recorded throughout study
COPD "Exacerbation days" recorded throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

Pacira Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

July 26, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (Estimate)

August 25, 2005

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFOR258F2402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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