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

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ClinicalTrials.gov Identifier: NCT01048333
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : October 25, 2012
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Formoterol
Drug: Salmeterol
Drug: Placebo
Enrollment 109
Recruitment Details Patients recruited at 14 clinics in 3 countries: Sweden (4 clinics); Italy (6 clinics); Spain (6 clinics)between January and May 2010
Pre-assignment Details 141 patients enrolled; 32 excluded: 28 due to eligibility criteria not fulfilled and 4 for subject decision
Arm/Group Title Formoterol, Then Salmeterol, Then Placebo Salmeterol, Then Palcebo, Then Formoterol Placebo, Then Formoterol, Then Salmeterol Formoterol, Then Placebo, Then Salmeterol Salmeterol, Then Formoterol, Then Placebo Placebo, Then Salmeterol, Then Formoterol
Hide Arm/Group Description Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Period Title: Treatment Period 1
Started 21 19 16 18 17 18
Completed 21 19 16 18 17 18
Not Completed 0 0 0 0 0 0
Period Title: Wash-Out Period 1 of 2 - 7 Days
Started 21 19 16 18 17 18
Completed 21 19 16 18 17 18
Not Completed 0 0 0 0 0 0
Period Title: Treatment Period 2
Started 21 19 16 18 17 18
Completed 21 19 16 18 17 18
Not Completed 0 0 0 0 0 0
Period Title: Wash-Out Period 2 of 2 - 7 Days
Started 21 19 16 18 17 18
Completed 21 18 16 18 17 18
Not Completed 0 1 0 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0             0
Period Title: Treatment Period 3
Started 21 18 16 18 17 18
Completed 21 18 16 18 17 18
Not Completed 0 0 0 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes all 3 arms : Formoterol, Salmeterol and Placebo.
Overall Number of Baseline Participants 109
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 109 participants
66.5
(41.0 to 84.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
Female
28
  25.7%
Male
81
  74.3%
1.Primary Outcome
Title FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
Hide Description FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1
Time Frame Pre-dose and 5 minutes post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Formoterol Salmeterol Placebo
Hide Arm/Group Description:
Formoterol Turbuhaler 9 mcg
Serevent Diskus (salmeterol) 50 mcg
Placebo salmeterol Diskus and Placebo Turbuhaler
Overall Number of Participants Analyzed 108 109 109
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage change
1.072
(1.055 to 1.088)
1.041
(1.025 to 1.057)
1.007
(0.992 to 1.023)
2.Secondary Outcome
Title Average FEV1 During the First 15 Minutes Post Dose
Hide Description Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1
Time Frame Pre dose and 15 minutes post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Formoterol Salmeterol Placebo
Hide Arm/Group Description:
Formoterol Turbuhaler 9 mcg
Serevent Diskus (salmeterol) 50 mcg
Placebo salmeterol Diskus and Placebo Turbuhaler
Overall Number of Participants Analyzed 108 109 109
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage change
1.064
(1.052 to 1.077)
1.041
(1.030 to 1.053)
1.012
(1.001 to 1.024)
3.Secondary Outcome
Title Average FEV1 During 120 Minutes Post Dose
Hide Description Average FEV1 during 120 minutes post dose, change versus pre dose FEV1
Time Frame Pre dose and 120 minutes post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Formoterol Salmeterol Placebo
Hide Arm/Group Description:
Formoterol Turbuhaler 9 mcg
Serevent Diskus (salmeterol) 50 mcg
Placebo salmeterol Diskus and Placebo Turbuhaler
Overall Number of Participants Analyzed 108 109 109
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage change
1.096
(1.079 to 1.112)
1.082
(1.066 to 1.098)
1.014
(0.999 to 1.029)
4.Secondary Outcome
Title Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
Hide Description 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
Time Frame Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Formoterol Salmeterol Placebo
Hide Arm/Group Description:
Formoterol Turbuhaler 9 mcg
Serevent Diskus (salmeterol) 50 mcg
Placebo salmeterol Diskus and Placebo Turbuhaler
Overall Number of Participants Analyzed 108 109 109
Measure Type: Number
Unit of Measure: Percentage of Participants
5 min 23.1 9.2 6.4
10 min 38.0 17.6 7.3
15 min 39.8 23.9 9.2
20 min 44.4 27.5 10.1
30 min 45.4 32.1 13.8
40 min 49.1 36.7 15.6
50 min 53.7 40.4 16.5
60 min 54.6 43.1 18.3
120 min 55.6 48.6 20.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Formoterol, Salmeterol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.090
Confidence Interval (2-Sided) 95%
1.31 to 3.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Formoterol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 6.534
Confidence Interval (2-Sided) 95%
3.55 to 12.02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Salmeterol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.127
Confidence Interval (2-Sided) 95%
1.77 to 5.52
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Adverse Events
Hide Description Number of participants with at least 1 AE.
Time Frame At baseline and at each day of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Formoterol Salmeterol Placebo
Hide Arm/Group Description:
Formoterol Turbuhaler 9 mcg
Serevent Diskus (salmeterol) 50 mcg
Placebo salmeterol Diskus and Placebo Turbuhaler
Overall Number of Participants Analyzed 108 109 109
Measure Type: Number
Unit of Measure: Participants
6 6 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Formoterol Salmeterol Placebo
Hide Arm/Group Description Formoterol Turbuhaler 9 mcg Serevent Diskus (salmeterol) 50 mcg Placebo salmeterol Diskus and Placebo Turbuhaler
All-Cause Mortality
Formoterol Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Formoterol Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/109 (0.00%)   0/109 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Formoterol Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/109 (0.00%)   0/109 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: Astra Zeneca
Phone: +44 1509 645895
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01048333     History of Changes
Other Study ID Numbers: D5127C00001
First Submitted: January 12, 2010
First Posted: January 13, 2010
Results First Submitted: September 9, 2011
Results First Posted: October 25, 2012
Last Update Posted: October 25, 2012