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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134979
• Other study ID #: CFOR258F2402
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2005
• Last updated: October 24, 2011
• Start date: October 2004
• Est. completion date: November 2005

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBrazil: National Health Surveillance AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyItaly: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Formoterol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

Switzerland, 

Outcome

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