Asthma Patients Clinical Trial
— SweapeaOfficial title:
A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.
| Status | Completed |
| Enrollment | 1144 |
| Est. completion date | February 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception - 6 months history of asthma according to ATS definition - Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2 - Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal - A total ACQ5 score of 1.5 or more Exclusion Criteria: - Respiratory infection significantly affecting the asthma - Any significant disease and disorder that may put the patient at risk or influence study results - Any clinically relevant abnormal findings - A smoking history of more than 10 pack years - Intake of oral, rectal or parenteral glucocorticosteroids |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Mendoza | |
| Argentina | Research Site | Quilmes | Buenos Aires |
| Argentina | Research Site | Rosario | Santa Fe |
| Argentina | Research Site | San Miguel de Tucuman | Tucuman |
| Brazil | Research Site | Belo Horizonte | MG |
| Brazil | Research Site | Florian Polis | Santa Catarina |
| Brazil | Research Site | Juiz de Fora | MG |
| Brazil | Research Site | Porto Alegre | RS |
| Brazil | Research Site | Porto Alegre | Brasil |
| Brazil | Research Site | Santo Andre | SP |
| Brazil | Research Site | Sao Paulo | SP |
| Brazil | Research Site | Vitoria | ES |
| Japan | Research Site | Asahikawa | Hokkaido |
| Japan | Research Site | Beppu | Oita |
| Japan | Research Site | Chitose | Hokkaido |
| Japan | Research Site | Chuo | Tokyo |
| Japan | Research Site | Chuo-ku | Tokyo |
| Japan | Research Site | Fujisawa-shi | Kanagawa |
| Japan | Research Site | Himeji | Hyogo |
| Japan | Research Site | Hiroshima-shi | Hiroshima |
| Japan | Research Site | Itabashi-ku | Tokyo |
| Japan | Research Site | Kitahiroshima | Hokkaido |
| Japan | Research Site | Kochi | |
| Japan | Research Site | Kodaira | Tokyo |
| Japan | Research Site | Kurashiki-shi | Okayama |
| Japan | Research Site | Kyoto | |
| Japan | Research Site | Matsue | Shimane |
| Japan | Research Site | Nagaoka | Niigata |
| Japan | Research Site | Naka-gun | Ibaraki |
| Japan | Research Site | Nakano-ku | Tokyo |
| Japan | Research Site | Obihiro | Hokkaido |
| Japan | Research Site | Ohota-ku | Tokyo |
| Japan | Research Site | Oita | |
| Japan | Research Site | Sakaide | Kagawa |
| Japan | Research Site | Sapporo | Hokkaido |
| Japan | Research Site | Tomakomai | Hokkaido |
| Japan | Research Site | Yanagawa | Fukuoka |
| Japan | Research Site | Yokohama | Kanagawa |
| Mexico | Research Site | Guadalajara | |
| Mexico | Research Site | Mexico | D.f. |
| Mexico | Research Site | Monterrey | Nuevo Leon |
| Mexico | Research Site | Morelia | Michoacan |
| Mexico | Research Site | Tijuana | Baja California |
| Romania | Research Site | Brasov | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Cluj Napoca | |
| Romania | Research Site | Constanta | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Tg. Mures | |
| Russian Federation | Research Site | Ekaterinburg | Russia |
| Russian Federation | Research Site | Moscow | Russia |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | St. Petersburg | |
| Russian Federation | Research Site | Vladikavkaz | |
| Slovakia | Research Site | Banska Bystrica | |
| Slovakia | Research Site | Bardejov | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Dunajska Streda | |
| Slovakia | Research Site | Hnusta | |
| Slovakia | Research Site | Komarno | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Levice | |
| Slovakia | Research Site | Liptovsky Hradok | |
| Slovakia | Research Site | Liptovsky Mikulas | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Rimavska Sobota | |
| Slovakia | Research Site | Ruzomberok | |
| Slovakia | Research Site | Trencin | |
| Slovakia | Research Site | Zvolen | |
| South Africa | Research Site | Amanzimtoti | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Durban | Kwazulu Natal |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Durbanville | |
| South Africa | Research Site | Lyttleton | Centurion |
| South Africa | Research Site | Pretoria | |
| South Africa | Research Site | Umkomaas | |
| Ukraine | Research Site | Dnipropetrovsk | |
| Ukraine | Research Site | Donetsk | |
| Ukraine | Research Site | Kharkiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Odesa | |
| Ukraine | Research Site | Poltava | |
| Ukraine | Research Site | Vinytsa | |
| Ukraine | Research Site | Zaporozhye | |
| United States | Research Site | Bellevue | Nebraska |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Clinton | South Carolina |
| United States | Research Site | Collegeville | Pennsylvania |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Mission Viejo | California |
| United States | Research Site | North Dartmouth | Massachusetts |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Rolling Hills Estates | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Jose | California |
| United States | Research Site | Sylvania | Ohio |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Waco | Texas |
| United States | Research Site | Wheaton | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Argentina, Brazil, Japan, Mexico, Romania, Russian Federation, Slovakia, South Africa, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pre-bronchodilator FEV1 at the Clinic | Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid. | Twelve week treatment period | No |
| Secondary | Morning and Evening PEF | Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid. | Twelve week treatment period | No |
| Secondary | Asthma Control Questionnaire 5-item (ACQ5) | The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline. | Twelve week treatment period | No |
| Secondary | Adverse Events | Number of participants who had at least one adverse event during the randomized treatment period | Twelve week treatment period | Yes |
| Secondary | Number of Participants With at Least One Severe Asthma Exacerbation | Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days | Twelve week treatment period | No |
| Secondary | Number of Participants With at Least One Treatment Failure | Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic. | Twelve week treatment period | No |
| Secondary | Number of Participants With Well-controlled Asthma (ACQ5<=0.75) | The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period. | Twelve week treatment period | No |
| Secondary | Asthma Quality of Life Questionnaire (AQLQ(S)) | The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline. | Twelve week treatment period | No |
| Secondary | Asthma Symptom Score | Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline. | Twelve week treatment period | No |
| Secondary | Total Reliever Medication Use | Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline. | Twelve week treatment period | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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