NCT01290874.
Methods |
Study design: RCT Study grouping: parallel group Open label: yes Cluster RCT: no |
|
Participants |
Baseline characteristics No full text available and no results posted on clinicaltrials.gov. The following baseline characteristics were not available for either group
Inclusion criteria: black people (self identified, with ≥ 1 biological parent identified as black; men or women aged 18‐75 years; ability to provide informed consent; clinical history consistent with asthma for > 1 year; ability to perform pulmonary function tests; FEV1 > 40% of predicted; receiving ICS/LABA combination therapy, or ICS moderate‐dose monotherapy; baseline ACQ > 1.25; non‐smoker for past year (total lifetime smoking history < 10 pack‐years) Exclusion criteria: use of equivalent of inhaled fluticasone > 1000 mcg daily; chronic use of OCS or Anti‐IgE for asthma; lung disease other than asthma or diagnosis of vocal cord dysfunction; significant unstable medical illness (other than asthma); pregnancy, lactation, or an unwillingness to maintain effective contraception; significant exacerbation of asthma or respiratory tract infection within 4 weeks; life‐threatening asthma within 5 years; hyposensitisation therapy other than an established maintenance regimen; use of inhaled anticholinergic therapy (ipratropium, tiotropium) within 1 month; known contraindication to inhaled tiotropium (e.g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy); inability to speak and read English |
|
Interventions |
Intervention characteristics LAMA add‐on
LABA add‐on
|
|
Outcomes | No full text available and no results posted on clinicaltrials.gov | |
Identification |
Sponsorship source: Brigham and Women's Hospital with collaboration from Olmsted Medical Center, American Academy of Family Physicians National Research Network, and Harvard Clinical Research Institute Country: US Setting: 13 medical centres and university sites in the US Comments: no results posted and no publications identified Authors name: Elliot Israel, MD Institution: Brigham and Women's Hospital Email: eisrael@partners.org Address: 75 Francis St Boston, MA 02115, US |
|
Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, no other details |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Study was open label |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details of number enrolled, number of withdrawals or number included in the analyses |
Selective reporting (reporting bias) | High risk | No data published. No publications provided or results posted on clinicaltrials.gov |
Other bias | Low risk | None noted |