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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Salmeterol, then Formoterol, then Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formoterol | Drug | Formoterol Turbuhaler 9 μg and Placebo Diskus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average FEV1 During the First 15 Minutes Post Dose | Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1 | Pre dose and 15 minutes post dose |
| Average FEV1 During 120 Minutes Post Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Cazzola, professor | Italy | Principal Investigator |
| Georgios Stratelis | AstraZeneca MC Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bussolengo | Italy | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22235841 | Derived | 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. |
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141 patients enrolled; 32 excluded: 28 due to eligibility criteria not fulfilled and 4 for subject decision
Patients recruited at 14 clinics in 3 countries: Sweden (4 clinics); Italy (6 clinics); Spain (6 clinics)between January and May 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Formoterol, Then Salmeterol, Then Placebo | Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler |
| FG001 | Salmeterol, Then Palcebo, Then Formoterol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler |
|
| 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 |
|
| Salmeterol | Drug | Salmeterol Diskus 50 μg and Placebo Turbuhaler |
|
| Placebo | Drug | Placebo Diskus and Placebo Turbuhaler |
|
Average FEV1 during 120 minutes post dose, change versus pre dose FEV1
| Pre dose and 120 minutes post dose |
| Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1 | 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 | Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose |
| Adverse Events | Number of participants with at least 1 AE. | At baseline and at each day of treatment |
| Cassano delle Murge |
| Italy |
| Research Site | Catanzaro | Italy |
| Research Site | Cava de' Tirreni | Italy |
| Research Site | Naples | Italy |
| Research Site | Palermo | Italy |
| Research Site | Parma | Italy |
| Research Site | Pisa | Italy |
| Research Site | Prato | Italy |
| Research Site | Roma | Italy |
| Research Site | Barcelona | Spain |
| Research Site | Madrid | Spain |
| Research Site | Málaga | Spain |
| Research Site | Gothenburg | Sweden |
| Research Site | Linköping | Sweden |
| Research Site | Luleå | Sweden |
| Research Site | Lund | Sweden |
Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus |
| FG002 | Placebo, Then Formoterol, Then Salmeterol | Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler |
| FG003 | Formoterol, Then Placebo, Then Salmeterol | Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler |
| FG004 | Salmeterol, Then Formoterol, Then Placebo | Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler |
| FG005 | Placebo, Then Salmeterol, Then Formoterol | Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus |
| COMPLETED |
|
| NOT COMPLETED |
|
| Wash-Out Period 1 of 2 - 7 Days |
|
| Treatment Period 2 |
|
| Wash-Out Period 2 of 2 - 7 Days |
|
|
| Treatment Period 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all 3 arms : Formoterol, Salmeterol and Placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Geometric Mean | 95% Confidence Interval | percentage change | Pre-dose and 5 minutes post-dose |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Average FEV1 During the First 15 Minutes Post Dose | Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1 | Posted | Geometric Mean | 95% Confidence Interval | percentage change | Pre dose and 15 minutes post dose |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Average FEV1 During 120 Minutes Post Dose | Average FEV1 during 120 minutes post dose, change versus pre dose FEV1 | Posted | Geometric Mean | 95% Confidence Interval | percentage change | Pre dose and 120 minutes post dose |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1 | 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 | Posted | Number | Percentage of Participants | Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events | Number of participants with at least 1 AE. | Posted | Number | Participants | At baseline and at each day of treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formoterol | Formoterol Turbuhaler 9 mcg | 0 | 108 | 0 | 108 | ||
| EG001 | Salmeterol | Serevent Diskus (salmeterol) 50 mcg | 0 | 109 | 0 | 109 | ||
| EG002 | Placebo | Placebo salmeterol Diskus and Placebo Turbuhaler | 0 | 109 | 0 | 109 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | Astra Zeneca | +44 1509 645895 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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