Skip to main content
OpenTrials
Completed

NCT Number: NCT01048333

Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®

* 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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Bussolengo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Formoterol

Drug

Formoterol Turbuhaler 9 μg and Placebo Diskus

Salmeterol

Drug

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Placebo

Drug

Placebo Diskus and Placebo Turbuhaler

Primary outcomes

  1. FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose

    Time frame: Pre-dose and 5 minutes post-dose

    FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1

Secondary outcomes

  1. Average FEV1 During the First 15 Minutes Post Dose

    Time frame: Pre dose and 15 minutes post dose

    Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1

  2. Average FEV1 During 120 Minutes Post Dose

    Time frame: Pre dose and 120 minutes post dose

    Average FEV1 during 120 minutes post dose, change versus pre dose FEV1

  3. Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1

    Time frame: Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose

    Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1

  4. Adverse Events

    Time frame: At baseline and at each day of treatment

    Number of participants with at least 1 AE.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 13, 2010
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.