Asthma Clinical Trial
Official title:
An Open-Label Randomized, Multicenter Study in Patients With Asthma to Evaluate the Effectiveness of Alvesco® (Ciclesonide) Compared to Asthma Usual Care in a Primary Practice Setting
| Verified date | September 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.
| Status | Completed |
| Enrollment | 1121 |
| Est. completion date | December 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Main inclusion criteria: - Written informed consent - 18 years or older with diagnosis of asthma for at least 6 months - Clinically stable asthma at the time of study enrollment - Clinical requirements for treatment with ICS as outlined in the Canadian Asthma Consensus Guidelines - If patients are currently on ICS, the dose must be stable for 3 months and they must be willing to switch Main exclusion criteria: - On combination therapy (ICS + long acting beta-2-agonist) for asthma in the past 3 months or require combination therapy - Severe asthma, one or more asthma exacerbations in the last 3 months requiring hospitalization or emergency room visit, or patients who have used systemic steroids more than 3 times in the past 6 months or who are currently using systemic steroids - Mild asthma requiring short acting beta-2-agonists only - Patients with a contraindication to ICS therapy - Any other disease or medical condition requiring further clinical evaluation, which in the opinion of the Primary Care Practitioner may interfere with the clinical study or interfere with the diagnosis of asthma. - Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women |
| Country | Name | City | State |
|---|---|---|---|
| Canada | "Altana Pharma/Nycomed" | Abbotsford | |
| Canada | "Altana Pharma/Nycomed" | Ajax | |
| Canada | "Altana Pharma/Nycomed" | Alma | |
| Canada | "Altana Pharma/Nycomed" | Anjou | |
| Canada | "Altana Pharma/Nycomed" | Anjou | |
| Canada | "Altana Pharma/Nycomed" | Barrie | |
| Canada | "Altana Pharma/Nycomed" | Brampton | |
| Canada | "Altana Pharma/Nycomed" | Brampton | |
| Canada | "Altana Pharma/Nycomed" | Brampton | |
| Canada | "Altana Pharma/Nycomed" | Brampton | |
| Canada | "Altana Pharma/Nycomed" | Brampton | |
| Canada | "Altana Pharma/Nycomed" | Brossard | |
| Canada | "Altana Pharma/Nycomed" | Burnaby | |
| Canada | "Altana Pharma/Nycomed" | Burnaby | |
| Canada | "Altana Pharma/Nycomed" | Cacouna | |
| Canada | "Altana Pharma/Nycomed" | Calgary | |
| Canada | "Altana Pharma/Nycomed" | Calgary | |
| Canada | "Altana Pharma/Nycomed" | Calgary | |
| Canada | "Altana Pharma/Nycomed" | Calgary | |
| Canada | "Altana Pharma/Nycomed" | Calgary | |
| Canada | "Altana Pharma/Nycomed" | Calgary | |
| Canada | "Altana Pharma/Nycomed" | Calgary | |
| Canada | "Altana Pharma/Nycomed" | Calgary | |
| Canada | "Altana Pharma/Nycomed" | Cambridge | |
| Canada | "Altana Pharma/Nycomed" | Collingwood | |
| Canada | "Altana Pharma/Nycomed" | Conception Bay S | |
| Canada | "Altana Pharma/Nycomed" | Cornwall | |
| Canada | "Altana Pharma/Nycomed" | Corunna | |
| Canada | "Altana Pharma/Nycomed" | Courcelette | |
| Canada | "Altana Pharma/Nycomed" | Delta | |
| Canada | "Altana Pharma/Nycomed" | Delta | |
| Canada | "Altana Pharma/Nycomed" | Dolbeau-Mistassini | |
| Canada | "Altana Pharma/Nycomed" | Edmonton | |
| Canada | "Altana Pharma/Nycomed" | Etobicoke | |
| Canada | "Altana Pharma/Nycomed" | Fort Erie | |
| Canada | "Altana Pharma/Nycomed" | Gatineau | |
| Canada | "Altana Pharma/Nycomed" | Gatineau | |
| Canada | "Altana Pharma/Nycomed" | Gatineau | |
| Canada | "Altana Pharma/Nycomed" | Gatineau | |
| Canada | "Altana Pharma/Nycomed" | Gatineau | |
| Canada | "Altana Pharma/Nycomed" | Gatineau | |
| Canada | "Altana Pharma/Nycomed" | Gatineau (Sector Hull) | |
| Canada | "Altana Pharma/Nycomed" | Grand Falls | |
| Canada | "Altana Pharma/Nycomed" | Halifax | |
| Canada | "Altana Pharma/Nycomed" | Harrow | |
| Canada | "Altana Pharma/Nycomed" | Hastings | |
| Canada | "Altana Pharma/Nycomed" | Hull | |
| Canada | "Altana Pharma/Nycomed" | Hull | |
| Canada | "Altana Pharma/Nycomed" | Joliette | |
| Canada | "Altana Pharma/Nycomed" | Joliette | |
| Canada | "Altana Pharma/Nycomed" | Jonquiere | |
| Canada | "Altana Pharma/Nycomed" | Kamloops | |
| Canada | "Altana Pharma/Nycomed" | Kentville | |
| Canada | "Altana Pharma/Nycomed" | Keswick | |
| Canada | "Altana Pharma/Nycomed" | Kingston | |
| Canada | "Altana Pharma/Nycomed" | Kirkland | |
| Canada | "Altana Pharma/Nycomed" | Lasalle | |
| Canada | "Altana Pharma/Nycomed" | Lasalle | |
| Canada | "Altana Pharma/Nycomed" | Laval | |
| Canada | "Altana Pharma/Nycomed" | London | |
| Canada | "Altana Pharma/Nycomed" | London | |
| Canada | "Altana Pharma/Nycomed" | London | |
| Canada | "Altana Pharma/Nycomed" | Milton | |
| Canada | "Altana Pharma/Nycomed" | Mississauga | |
| Canada | "Altana Pharma/Nycomed" | Mississauga | |
| Canada | "Altana Pharma/Nycomed" | Mississauga | |
| Canada | "Altana Pharma/Nycomed" | Mississauga | |
| Canada | "Altana Pharma/Nycomed" | Mississauga | |
| Canada | "Altana Pharma/Nycomed" | Mississauga | |
| Canada | "Altana Pharma/Nycomed" | Moncton | |
| Canada | "Altana Pharma/Nycomed" | Montreal | |
| Canada | "Altana Pharma/Nycomed" | Montreal | |
| Canada | "Altana Pharma/Nycomed" | Montreal | |
| Canada | "Altana Pharma/Nycomed" | Montreal | |
| Canada | "Altana Pharma/Nycomed" | Montreal | |
| Canada | "Altana Pharma/Nycomed" | Montreal | |
| Canada | "Altana Pharma/Nycomed" | Montreal | |
| Canada | "Altana Pharma/Nycomed" | Montreal | |
| Canada | "Altana Pharma/Nycomed" | Mount Pearl | |
| Canada | "Altana Pharma/Nycomed" | Mount Pearl | |
| Canada | "Altana Pharma/Nycomed" | Niagara Falls | |
| Canada | "Altana Pharma/Nycomed" | North Bay | |
| Canada | "Altana Pharma/Nycomed" | North Sydney | |
| Canada | "Altana Pharma/Nycomed" | North Vancouver | |
| Canada | "Altana Pharma/Nycomed" | North Vancouver | |
| Canada | "Altana Pharma/Nycomed" | North Vancouver | |
| Canada | "Altana Pharma/Nycomed" | North York | |
| Canada | "Altana Pharma/Nycomed" | Oakville | |
| Canada | "Altana Pharma/Nycomed" | Oshawa | |
| Canada | "Altana Pharma/Nycomed" | Oshawa | |
| Canada | "Altana Pharma/Nycomed" | Ottawa | |
| Canada | "Altana Pharma/Nycomed" | Ottawa | |
| Canada | "Altana Pharma/Nycomed" | Ottawa | |
| Canada | "Altana Pharma/Nycomed" | Penticton | |
| Canada | "Altana Pharma/Nycomed" | Penticton | |
| Canada | "Altana Pharma/Nycomed" | Perth Andover | |
| Canada | "Altana Pharma/Nycomed" | Point Edward | |
| Canada | "Altana Pharma/Nycomed" | Pointe-Claire | |
| Canada | "Altana Pharma/Nycomed" | Princeville | |
| Canada | "Altana Pharma/Nycomed" | Quebec | |
| Canada | "Altana Pharma/Nycomed" | Quebec | |
| Canada | "Altana Pharma/Nycomed" | Quebec | |
| Canada | "Altana Pharma/Nycomed" | Red Deer | |
| Canada | "Altana Pharma/Nycomed" | Regina | |
| Canada | "Altana Pharma/Nycomed" | Regina | |
| Canada | "Altana Pharma/Nycomed" | Repentigny | |
| Canada | "Altana Pharma/Nycomed" | Richmond | |
| Canada | "Altana Pharma/Nycomed" | Richmond Hill | |
| Canada | "Altana Pharma/Nycomed" | Rimouski | |
| Canada | "Altana Pharma/Nycomed" | Roxton Pond | |
| Canada | "Altana Pharma/Nycomed" | Saint John | |
| Canada | "Altana Pharma/Nycomed" | Sainte-Catherine | |
| Canada | "Altana Pharma/Nycomed" | Sarnia | |
| Canada | "Altana Pharma/Nycomed" | Saskatoon | |
| Canada | "Altana Pharma/Nycomed" | Saskatoon | |
| Canada | "Altana Pharma/Nycomed" | Scarborough | |
| Canada | "Altana Pharma/Nycomed" | Scarborough | |
| Canada | "Altana Pharma/Nycomed" | Sherbrooke | |
| Canada | "Altana Pharma/Nycomed" | Shubenacadie | |
| Canada | "Altana Pharma/Nycomed" | St Bruno | |
| Canada | "Altana Pharma/Nycomed" | St-Jean-sur-Richel | |
| Canada | "Altana Pharma/Nycomed" | St-Jerome | |
| Canada | "Altana Pharma/Nycomed" | St-Pie | |
| Canada | "Altana Pharma/Nycomed" | St. Catharines | |
| Canada | "Altana Pharma/Nycomed" | St. John's | |
| Canada | "Altana Pharma/Nycomed" | St. John's | |
| Canada | "Altana Pharma/Nycomed" | St. John's | |
| Canada | "Altana Pharma/Nycomed" | St. John's | |
| Canada | "Altana Pharma/Nycomed" | St. Leonard | |
| Canada | "Altana Pharma/Nycomed" | St. Romuald | |
| Canada | "Altana Pharma/Nycomed" | Ste Anne De Bellev | |
| Canada | "Altana Pharma/Nycomed" | Stirling | |
| Canada | "Altana Pharma/Nycomed" | Stouffville | |
| Canada | "Altana Pharma/Nycomed" | Sudbury | |
| Canada | "Altana Pharma/Nycomed" | Sudbury | |
| Canada | "Altana Pharma/Nycomed" | Surrey | |
| Canada | "Altana Pharma/Nycomed" | Surrey | |
| Canada | "Altana Pharma/Nycomed" | Surrey | |
| Canada | "Altana Pharma/Nycomed" | Surrey | |
| Canada | "Altana Pharma/Nycomed" | Surrey | |
| Canada | "Altana Pharma/Nycomed" | Sydney Mines | |
| Canada | "Altana Pharma/Nycomed" | Thetford Mines | |
| Canada | "Altana Pharma/Nycomed" | Thornhill | |
| Canada | "Altana Pharma/Nycomed" | Thunder Bay | |
| Canada | "Altana Pharma/Nycomed" | Thunder Bay | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Toronto | |
| Canada | "Altana Pharma/Nycomed" | Vancouver | |
| Canada | "Altana Pharma/Nycomed" | Vancouver | |
| Canada | "Altana Pharma/Nycomed" | Vancouver | |
| Canada | "Altana Pharma/Nycomed" | Vancouver | |
| Canada | "Altana Pharma/Nycomed" | Vancouver | |
| Canada | "Altana Pharma/Nycomed" | Verdun | |
| Canada | "Altana Pharma/Nycomed" | Verdun | |
| Canada | "Altana Pharma/Nycomed" | Victoria | |
| Canada | "Altana Pharma/Nycomed" | West Vancouver | |
| Canada | "Altana Pharma/Nycomed" | Westmount | |
| Canada | "Altana Pharma/Nycomed" | Whitby | |
| Canada | "Altana Pharma/Nycomed" | Windsor | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Winnipeg | |
| Canada | "Altana Pharma/Nycomed" | Woodstock | |
| Canada | "Altana Pharma/Nycomed" | Woodstock | |
| Canada | "Altana Pharma/Nycomed" | York | |
| Canada | "Altana Pharma/Nycomed" | York |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) | The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome). | At the middle and end of the 12 week treatment period | |
| Secondary | Change in Patient Assessment of Asthma Control | Patient assessment of asthma control was assessed at baseline and at week 12 using the question "How would you rate the control of your asthma symptoms?". The change in this assessment was categorized in "Improvement" and "Non-Improvement". | At baseline and at week 12 | |
| Secondary | Assessment of Patient Compliance During the Study | 12 weeks | ||
| Secondary | Assessment of Patient Treatment Satisfaction | 12 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
| Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
| Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
| Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
| Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
| Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
| Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
| Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
| Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
| Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
| Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|