NCT01048333

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)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
3 countries

17 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

January 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.5 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

4 months

First QC Date

January 12, 2010

Results QC Date

September 9, 2011

Last Update Submit

September 25, 2012

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary DiseaseOnset of effectCOPDOxis Turbuhaler

Outcome Measures

Primary Outcomes (1)

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

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

    Pre-dose and 5 minutes post-dose

Secondary Outcomes (4)

  • Average FEV1 During the First 15 Minutes Post Dose

    Pre dose and 15 minutes post dose

  • Average FEV1 During 120 Minutes Post Dose

    Pre dose and 120 minutes post dose

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

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

  • Adverse Events

    At baseline and at each day of treatment

Study Arms (6)

Formoterol, then Salmeterol, then Placebo

EXPERIMENTAL

Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler

Drug: FormoterolDrug: SalmeterolDrug: Placebo

Salmeterol, then Palcebo, then Formoterol

EXPERIMENTAL

Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus

Drug: FormoterolDrug: SalmeterolDrug: Placebo

Placebo, then Formoterol, then Salmeterol

EXPERIMENTAL

Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler

Drug: FormoterolDrug: SalmeterolDrug: Placebo

Formoterol, then Placebo, then Salmeterol

EXPERIMENTAL

Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler

Drug: FormoterolDrug: SalmeterolDrug: Placebo

Salmeterol, then Formoterol, then Placebo

EXPERIMENTAL

Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler

Drug: FormoterolDrug: SalmeterolDrug: Placebo

Placebo, then Salmeterol, then Formoterol

EXPERIMENTAL

Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus

Drug: FormoterolDrug: SalmeterolDrug: Placebo

Interventions

FormoterolDRUG

Formoterol Turbuhaler 9 μg and Placebo Diskus

Formoterol, then Placebo, then SalmeterolFormoterol, then Salmeterol, then PlaceboPlacebo, then Formoterol, then SalmeterolPlacebo, then Salmeterol, then FormoterolSalmeterol, then Formoterol, then PlaceboSalmeterol, then Palcebo, then Formoterol
SalmeterolDRUG

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Formoterol, then Placebo, then SalmeterolFormoterol, then Salmeterol, then PlaceboPlacebo, then Formoterol, then SalmeterolPlacebo, then Salmeterol, then FormoterolSalmeterol, then Formoterol, then PlaceboSalmeterol, then Palcebo, then Formoterol
PlaceboDRUG

Placebo Diskus and Placebo Turbuhaler

Formoterol, then Placebo, then SalmeterolFormoterol, then Salmeterol, then PlaceboPlacebo, then Formoterol, then SalmeterolPlacebo, then Salmeterol, then FormoterolSalmeterol, then Formoterol, then PlaceboSalmeterol, then Palcebo, then Formoterol

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Research Site

Bussolengo, Italy

Location

Research Site

Cassano delle Murge, Italy

Location

Research Site

Catanzaro, Italy

Location

Research Site

Cava de' Tirreni, Italy

Location

Research Site

Napoli, Italy

Location

Research Site

Palermo, Italy

Location

Research Site

Parma, Italy

Location

Research Site

Pisa, Italy

Location

Research Site

Prato, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Barcelona, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Lund, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 22235841DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol FumarateSalmeterol Xinafoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesAlbuterolPhenethylaminesEthylamines

Results Point of Contact

Title
Gerard Lynch
Organization
Astra Zeneca
ClinicalTrialTransparency@astrazeneca.com
+44 1509 645895

Study Officials

  • Mario Cazzola, professor

    Italy

    PRINCIPAL INVESTIGATOR

  • Georgios Stratelis

    AstraZeneca MC Sweden

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 25, 2012

Results First Posted

October 25, 2012

Record last verified: 2012-09

Locations

ES(3)SE(4)IT(10)