Clinical trial NCT01048333: Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®
Official title: A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Onset of effect
COPD
Oxis Turbuhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 109
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: * Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
* Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms
* A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).
* Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.

Exclusion Criteria:

* A history and/or current diagnosis of asthma.
* Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.
* A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.

Primary outcomes:
measure: FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
timeFrame: Pre-dose and 5 minutes post-dose
Secondary outcomes:
measure: Average FEV1 During the First 15 Minutes Post Dose
timeFrame: Pre dose and 15 minutes post dose
measure: Average FEV1 During 120 Minutes Post Dose
timeFrame: Pre dose and 120 minutes post dose
measure: Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
timeFrame: Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose
measure: Adverse Events
timeFrame: At baseline and at each day of treatment
Other outcomes:
Locations:
city: Bussolengo
country: Italy
facility: Research Site
city: Cassano Delle Murge
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Cava dei Tirreni
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Prato
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: Italy
name: Mario Cazzola, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca MC Sweden
name: Georgios Stratelis
role: STUDY_DIRECTOR
References:
citation: Cazzola M, Paggiaro P, Palange P, Bjermer L, Ausin P, Carlsson LG, Ekelund J, Lotvall J. Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study. Clin Drug Investig. 2012 Mar 1;32(3):147-55. doi: 10.2165/11630880-000000000-00000.